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Latest European Medicines Agency (EMA) News

Aldeyra Therapeutics Receives Orphan Designation from the European Medicines Agency for ADX-2191 for the Treatment of Primary Large B-Cell Lymphomas of Immune-Privileged Sites, including Primary Vitreoretinal Lymphoma

August 28
Last Trade: 5.84 -0.02 -0.34

LEXINGTON, Mass. / Aug 28, 2025 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the European Medicines Agency (EMA) has granted Orphan Designation for ADX-2191 (methotrexate intravitreal injection, USP) for the treatment of primary large B-Cell lymphomas of immune-privileged sites, including primary vitreoretinal lymphoma. There is currently no approved treatment for patients with primary...Read more


Advanz Pharma and Alvotech receive European approval for Mynzepli®, Biosimilar to Eylea®

August 21
Last Trade: 8.07 0.02 0.25

Mynzepli® (aflibercept) is approved in all European Economic Area member countries for the treatment of various retinal diseases including neovascular (wet) age-related macular degeneration (AMD) Approval is based on comprehensive analytical, non-clinical and clinical similarity data, including a confirmatory efficacy study comparing Mynzepli® with the reference biologic Eylea® in patients with neovascular AMD REYKJAVIK, Iceland and...Read more


Madrigal Pharmaceuticals Receives European Commission Approval for Rezdiffra™ (resmetirom) for the Treatment of MASH with Moderate to Advanced Liver Fibrosis

August 19
Last Trade: 436.10 -1.07 -0.24

Rezdiffra is the first and only medication approved for people living with MASH in the European Union   Conditional marketing authorization is based on positive results from the pivotal Phase 3 MAESTRO-NASH trial demonstrating Rezdiffra reduced fibrosis, resolved MASH and improved key noninvasive tests Rezdiffra is already included in European MASH treatment guidelines as a first-line treatment Madrigal is planning for its...Read more


SpringWorks Therapeutics: European Commission Grants Approval of OGSIVEO® (nirogacestat) for the Treatment of Adults with Desmoid Tumors

August 18
Last Trade: 46.99 0.00 0.00

OGSIVEO is the first and only therapy to receive marketing authorization in the EU for the treatment of desmoid tumors STAMFORD, Conn., Aug. 18, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany, announced today that the European Commission (EC) granted marketing authorization for OGSIVEO® (nirogacestat), an oral gamma secretase inhibitor, as monotherapy for the treatment...Read more


NewAmsterdam Pharma Announces Acceptance of Marketing Authorization Applications for Review by European Medicine Agency for Obicetrapib

August 18
Last Trade: 24.05 0.10 0.42

Filings both for the obicetrapib monotherapy and obicetrapib plus ezetimibe fixed-dose combination submitted to EMA by our partner, Menarini, for treatment of adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia  NewAmsterdam entitled to tiered double-digit percentage royalties ranging from the low double-digits to mid-twenties on net sales in the Menarini Territory and up to an...Read more


Ascentage Pharma Announces Global Registrational Phase III Study of Lisaftoclax for First-line Treatment of Patients with Higher-Risk Myelodysplastic Syndrome Cleared by US FDA and EMA

August 17
Last Trade: 42.38 1.25 3.04

ROCKVILLE, Md. and SUZHOU, China, Aug. 17, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced that it has received clearance by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)...Read more


Ocugen Announces Positive Scientific Advice from the European Medicines Agency Related to the Approval Pathway for OCU410ST—Modifier Gene Therapy for Stargardt Disease

August 13
Last Trade: 1.02 -0.03 -2.86

MALVERN, Pa., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) reviewed the study design, endpoints and planned statistical analysis of the ongoing pivotal confirmatory OCU410ST Phase 2/3 GARDian3 clinical...Read more


KalVista Pharmaceuticals Announces Maintenance of Orphan Designation for Sebetralstat in European Union

August 11
Last Trade: 13.46 -0.06 -0.44

Sebetralstat is one of only two hereditary angioedema therapies to maintain orphan designation, underscoring its major contribution to patient care If approved, sebetralstat will be granted 10 years of market exclusivity in EU CAMBRIDGE, Mass. & SALISBURY, England / Aug 11, 2025 / Business Wire / KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Committee for Orphan Medicinal Products (COMP) of the European...Read more


Annexon Selected by EMA to Participate in Product Development Coordinator Pilot for Vonaprument (ANX007) for Dry Age-Related Macular Degeneration with Geographic Atrophy

August 7
Last Trade: 2.06 -0.06 -2.83

New Pilot Appoints Designated Product Development Coordinator to Navigate Regulatory Interactions, Respond to Ad-hoc Queries, and Support Evidence Planning Vonaprument Selected by EMA as One of ~20 PRIME Development Programs in the Pilot Vonaprument Has the Potential to Be the First Treatment Approved in Europe and the U.S. for Dry AMD with Geographic Atrophy Based on Protection of Visual Acuity and Visual Structures BRISBANE,...Read more


Certara Simcyp® Simulator Becomes First and Only Software Platform to Receive EMA Qualification Opinion for PBPK Modeling

August 4
Last Trade: 10.84 -0.05 -0.46

RADNOR, Pa., Aug. 04, 2025 (GLOBE NEWSWIRE) -- Certara, Inc., a global leader in biosimulation, today announced that the European Medicines Agency (EMA) has formally qualified the Simcyp® Simulator for use in regulatory submissions across the EU. Certara is the first company to receive EMA qualification for a PBPK modeling platform, and Simcyp is the only software to hold this designation. The recognition follows a rigorous multi-year,...Read more


Moderna Receives European Commission Approval for Updated COVID-19 Vaccine Targeting SARS-CoV-2 Variant LP.8.1

July 30
Last Trade: 24.09 -0.38 -1.55

CAMBRIDGE, MA / ACCESS Newswire / July 30, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission (EC) has granted marketing authorization for the updated formulation of the COVID-19 vaccine Spikevax®, targeting the SARS-CoV-2 variant LP.8.1, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and older. This marketing authorization follows the Positive Opinion from...Read more


Zevra Therapeutics Submits Marketing Authorization Application to European Medicines Agency to Review Arimoclomol for the Treatment of Niemann-Pick Disease Type C

July 28
Last Trade: 9.07 -0.23 -2.47

CELEBRATION, Fla., July 28, 2025 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living with rare diseases, announced the company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the evaluation of arimoclomol for the treatment of Niemann-Pick Disease Type C (NPC). NPC is an ultra-rare,...Read more


Sarepta Therapeutics Acknowledges CHMP Negative Opinion for ELEVIDYS in the European Union

July 25
Last Trade: 18.20 -0.14 -0.76

Partner Roche will continue its dialogue with the European Medicines Agency to explore a potential path forward to make ELEVIDYS available to individuals living with Duchenne muscular dystrophy in the EU ELEVIDYS is the first and only disease-modifying gene therapy for Duchenne CAMBRIDGE, Mass. / Jul 25, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases,...Read more


KalVista Pharmaceuticals Receives Positive CHMP Opinion for Sebetralstat for the Treatment of Hereditary Angioedema Attacks

July 25
Last Trade: 13.46 -0.06 -0.44

If approved, sebetralstat will be the first and only oral on-demand treatment for HAE in the European Union (EU) European Commission decision expected by early October 2025 CAMBRIDGE, Mass. & SALISBURY, England / Jul 25, 2025 / Business Wire / KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive...Read more


European regulatory authority adopts positive opinion for Novo Nordisk’s Alhemo® (concizumab), recommending label expansion to treat haemophilia A and B without inhibitors

July 25
Last Trade: 56.46 0.35 0.62

Pending European Commission (EC) approval, Alhemo® will become available to all adult and paediatric patients 12 years and older living with severe haemophilia A and moderate or severe haemophilia B without inhibitors. This positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is based on results from the explorer8 trial, which showed that Alhemo® reduced spontaneous and...Read more


Pfizer and BioNTech Receive Positive CHMP Opinion for LP.8.1-adapted COVID-19 Vaccine in the European Union

July 25
Last Trade: 24.76 0.16 0.65

Data indicate that the LP.8.1-adapted COVID-19 vaccine confers improved immune response against currently dominant and emerging sublineages – including the XFG and NB.1.8.1 variants1 – compared to 2024-2025 COVID-19 vaccine formulations Upon authorization by the European Commission (EC), the LP.8.1-adapted COVID-19 vaccine will be available for individuals 6 months of age and older To date, over a billion adults and children around the...Read more


EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Authorization of Moderna's COVID-19 mRNA Vaccine Targeting the SARS-CoV-2 Variant LP.8.1

July 25
Last Trade: 24.09 -0.38 -1.55

Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European Commission authorization decision CAMBRIDGE, MA / ACCESS Newswire / July 25, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for an updated formulation of...Read more


Biogen: ZURZUVAE® (zuranolone) Receives Positive Opinion from CHMP for the Treatment of Women with Postpartum Depression

July 25
Last Trade: 132.22 -0.43 -0.32

CAMBRIDGE, Mass., July 25, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorization for ZURZUVAE® (zuranolone) for the treatment of postpartum depression (PPD) in adults following childbirth. If approved by the European Commission (EC), ZURZUVAE will be the first treatment...Read more


Ionis Pharmaceuticals: TRYNGOLZA® (olezarsen) recommended for approval in the EU by CHMP for familial chylomicronemia syndrome (FCS)

July 25
Last Trade: 42.64 0.02 0.05

Recommendation based on Phase 3 Balance results, which showed a significant reduction of triglycerides and substantial reduction of acute pancreatitis events with TRYNGOLZA European Commission decision expected by Q4 2025 CARLSBAD, Calif. / Jul 25, 2025 / Business Wire / Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) and Sobi® today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency...Read more


Eli Lilly: Donanemab receives positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in early symptomatic Alzheimer's disease

July 25
Last Trade: 732.58 0.62 0.08

The opinion will now be referred to the European Commission for final regulatory decision on donanemab  INDIANAPOLIS, July 25, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending donanemab for the treatment of early symptomatic Alzheimer's disease in adults with confirmed...Read more


Gilead Sciences Receives Positive CHMP Opinions Under Accelerated Review From European Medicines Agency for Twice-Yearly Lenacapavir for HIV Prevention

July 25
Last Trade: 113.08 0.52 0.46

If Approved, Lenacapavir Would Be the First and Only Twice-Yearly HIV PrEP Option in the European Union Positive Opinion Also Received for EMA’s EU-M4all Procedure, Designed to Facilitate Availability in Low- and Lower-Middle-Income Countries FOSTER CITY, Calif. / Jul 25, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines...Read more


Candel Therapeutics Receives EMA Orphan Designation for CAN-2409 for the Treatment of Pancreatic Cancer

July 24
Last Trade: 5.79 -0.03 -0.52

NEEDHAM, Mass., July 24, 2025 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that the European Medicines Agency (EMA) has granted Orphan Designation for CAN-2409 (aglatimagene besadenovec) for the treatment of pancreatic cancer. This designation...Read more


Aldeyra Therapeutics Receives Orphan Designation from the European Medicines Agency for ADX-2191 for the Treatment of Inherited Retinal Dystrophies including Retinitis Pigmentosa

July 24
Last Trade: 5.84 -0.02 -0.34

LEXINGTON, Mass. / Jul 24, 2025 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the European Medicines Agency (EMA) has granted Orphan Designation for ADX-2191 (methotrexate intravitreal injection) for the treatment of inherited retinal dystrophies of the rod-dominant phenotype, including retinitis pigmentosa. There are currently no approved drug treatments for patients with most forms of retinitis...Read more


Halozyme Therapeutics: European Commission Approved DARZALEX Faspro® for Adult Patients with Smouldering Multiple Myeloma

July 23
Last Trade: 73.15 0.34 0.47

DARZALEX Faspro® is co-formulated with Halozyme's ENHANZE® drug delivery technology Approval represents critical advancement in early intervention for multiple myeloma SAN DIEGO, July 23, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson & Johnson company, received European Commission (EC) approval of a new indication for DARZALEX Faspro®...Read more


Korro Bio Receives European Medicines Agency Orphan Drug Designation for KRRO-110

July 21
Last Trade: 23.42 -0.25 -1.06

CAMBRIDGE, Mass., July 21, 2025 (GLOBE NEWSWIRE) -- Korro Bio, Inc. (Korro) (Nasdaq: KRRO), a clinical-stage biopharmaceutical company focused on developing a new class of genetic medicines based on editing RNA for both rare and highly prevalent diseases, announced today that it has been granted orphan drug designation by the European Medicines Agency (EMA) Committee, who adopted a positive opinion on KRRO-110, Korro’s investigational...Read more


SpringWorks Therapeutics: European Commission Grants Conditional Approval of EZMEKLY® (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN

July 18
Last Trade: 46.99 0.00 0.00

EZMEKLY is the first and only therapy to receive marketing authorization in the EU for both adults and children (≥2 years) with NF1-PN, a rare genetic disorder with debilitating symptoms STAMFORD, Conn., July 18, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany, announced today that the European Commission (EC) granted conditional marketing authorization for EZMEKLY®...Read more


Biodexa Pharmaceuticals Announces Filing of CTA in Europe for Phase 3 Serenta Trial in Familial Adenomatous Polyposis (FAP)

July 14
Last Trade: 5.54 0.07 1.28

Biodexa Announces Filing of CTA in Europe for Phase 3 Serenta Trial in Familial Adenomatous Polyposis (FAP) Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, announced the filing of a Clinical Trial Application (CTA) with the European Medicines Agency (EMA) for its...Read more


Novo Nordisk: New Wegovy® dose submitted to European Medicines Agency for approval, with 1 in 3 trial participants achieving 25% or more weight loss

July 8
Last Trade: 56.46 0.35 0.62

Bagsværd, Denmark, 8 July 2025 – Novo Nordisk today announced the submission of an application to the European Medicines Agency (EMA) for approval of a new, higher dose of its obesity treatment, Wegovy® (subcutaneous semaglutide 7.2 mg). This marks another significant milestone in the company’s goal to provide a broad portfolio of innovative and person-centric solutions to support people living with obesity, as part of their...Read more


Nurix Therapeutics: European Medicines Agency Grants Bexobrutideg (NX-5948) Orphan Drug Designation for the Treatment of Lymphoplasmacytic Lymphoma, also Known as Waldenström Macroglobulinemia

July 7
Last Trade: 9.34 -0.07 -0.74

Regulatory momentum builds for bexobrutideg with multiple designations across the United States and EU, Including EMA PRIME and FDA Fast Track for CLL/SLL SAN FRANCISCO, July 07, 2025 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, today announced that the European Medicines...Read more


Jazz Pharmaceuticals Receives European Commission Marketing Authorization for Ziihera® (zanidatamab) for the Treatment of Advanced HER2-Positive Biliary Tract Cancer

July 1
Last Trade: 127.75 1.62 1.28

Conditional approval based on positive results from the HERIZON-BTC-01 Phase 2b trial  DUBLIN, July 1, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the European Commission (EC) has granted conditional marketing authorization1 for Ziihera® (zanidatamab), a dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, as monotherapy for the treatment of adults with...Read more


Omeros Submits Narsoplimab Marketing Authorization Application to the European Medicines Agency for the Treatment of TA-TMA

June 27
Last Trade: 4.16 -0.07 -1.65

SEATTLE / Jun 27, 2025 / Business Wire / Omeros Corporation (Nasdaq: OMER) today announced the recent submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). The MAA includes response-based analyses in narsoplimab-treated TA-TMA patients as well as analyses comparing overall...Read more


Femasys Announces Historic Milestone with European Approval of FemBloc®, the First Non-Surgical Permanent Birth Control

June 25
Last Trade: 0.36 -0.0017 -0.48

European CE mark approval of the entire FemBloc® system marks pivotal achievement in expanding safe, accessible and non-surgical permanent contraceptive options for women ATLANTA, June 25, 2025 (GLOBE NEWSWIRE) -- Femasys Inc., (Nasdaq: FEMY), a leading biomedical innovator addressing significant unmet needs in women's health worldwide, with a broad portfolio of disruptive, accessible, in-office therapeutic and diagnostic products,...Read more


Novo Nordisk: Ozempic® receives EU recommendation in peripheral arterial disease, cementing the broad benefits of semaglutide for people with type 2 diabetes and comorbidities

June 23
Last Trade: 56.46 0.35 0.62

Pending a decision from the European Commission, Ozempic® (once-weekly semaglutide) will have the broadest approved label in the glucagon-like peptide-1 receptor agonist (GLP-1 RA) class, demonstrating improvements in blood sugar, weight, cardiovascular (CV) events, chronic kidney disease and peripheral arterial disease (PAD) functional outcomes1. Ozempic® is the first and only glucose-lowering treatment with proven functional...Read more


PTC Therapeutics: Sephience™ (sepiapterin) Granted Marketing Authorization by the European Commission for the Treatment of Children and Adults Living with Phenylketonuria (PKU)

June 23
Last Trade: 49.33 -0.46 -0.92

Broad label inclusive of all ages and disease severities  Launch to be initiated in Germany  WARREN, N.J., June 23, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that Sephience™ (sepiapterin) was granted marketing authorization by the European Commission for the treatment of children and adults living with phenylketonuria (PKU). The authorization includes a broad label inclusive of all ages and...Read more


European Medicines Agency Recommends Market Approval of AVT06, Alvotech’s Proposed Biosimilar to Eylea® (aflibercept)

June 23
Last Trade: 8.07 0.02 0.25

REYKJAVIK, Iceland and LONDON, June 23, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency’s (EMA) Committee for...Read more


argenx Announces European Commission Approval of VYVGART Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy

June 20
Last Trade: 712.20 7.27 1.03

VYVGART® SC, first-and-only IgG Fc-antibody fragment which specifically targets the neonatal Fc receptor (FcRn), now approved for use in Europe for CIDP Approval based on ADHERE clinical trial, the largest study of CIDP patients to date First novel mechanism of action for CIDP treatment in more than 30 years Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the...Read more


SpringWorks Therapeutics Receives Positive CHMP Opinion for Nirogacestat for the Treatment of Adults with Desmoid Tumors

June 20
Last Trade: 46.99 0.00 0.00

– If approved, nirogacestat will be the first and only therapy with marketing authorization in the EU for the treatment of desmoid tumors – – Decision from European Commission expected in the third quarter of 2025 – STAMFORD, Conn., June 20, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the European...Read more


Madrigal Pharmaceuticals Receives Positive CHMP Opinion for Resmetirom (Rezdiffra™) for the Treatment of MASH with Moderate to Advanced Liver Fibrosis

June 20
Last Trade: 436.10 -1.07 -0.24

Positive recommendation based on resmetirom’s favorable profile including positive results from the pivotal Phase 3 MAESTRO-NASH trial European Commission decision expected in August 2025; if approved, resmetirom will be the first medication for people living with MASH in the E.U.   CONSHOHOCKEN, Pa., June 20, 2025 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused on...Read more


Alnylam Pharmaceuticals Receives European Commission Approval for AMVUTTRA® (vutrisiran) for the Treatment of ATTR Amyloidosis with Cardiomyopathy

June 9
Last Trade: 446.51 -5.82 -1.29

First and Only RNAi Therapeutic Approved by the European Commission for the Treatment of Wild-Type or Hereditary ATTR Amyloidosis with Cardiomyopathy  Novel RNAi Mechanism Delivers Rapid Knockdown of Transthyretin (TTR), Addressing the Disease at its Source  Approval Based on HELIOS-B Phase 3 Study, Which Showed Up to 36% Reduction in All-Cause Mortality, With Preservation of Functional Capacity and Quality of Life, with Four...Read more


Tempest Therapeutics Receives Orphan Drug Designation from the European Medicines Agency for Amezalpat for the Treatment of Patients with HCC

June 5
Last Trade: 9.92 0.07 0.71

EMA Orphan Drug Designation (ODD) builds on U.S. Food & Drug Administration (FDA) ODD and Fast Track Designation, underscoring the urgent need for new treatment options The multiple regulatory designations were granted following strong positive results from a global randomized Phase 1b/2 study in first-line HCC demonstrating superior outcomes for amezalpat combination therapy across multiple study endpoints, including overall...Read more


Takeda: European Commission Approves ADCETRIS® (brentuximab vedotin) for the Treatment of Adult Patients with Newly Diagnosed Stage IIb/III/IV Hodgkin Lymphoma in Combination with ECADD

June 3
Last Trade: 14.99 0.02 0.13

Approval Based on Positive Results from the Phase 3 HD21 Trial for Stage IIb with Risk Factors/III/IV Hodgkin Lymphoma ADCETRIS-based Combination Demonstrated Superior Safety Profile and Efficacy Compared to eBEACOPP, a Standard of Care Regimen in Europe Second Approval in Frontline Hodgkin Lymphoma Broadens ADCETRIS’ Therapeutic Reach, Adding to Six Previously Approved, Distinct Indications for ADCETRIS in the European Union OSAKA,...Read more


Halozyme Therapeutics Announces Bristol Myers Squibb Received European Commission Approval for Subcutaneous Opdivo® (nivolumab) Co-Formulated with ENHANZE® Across Multiple Solid Tumor Indications

May 28
Last Trade: 73.15 0.34 0.47

Opdivo® is the first and only PD-1 inhibitor approved for subcutaneous (SC) use in the European Union SAN DIEGO, May 28, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Bristol Myers Squibb received European Commission (EC) approval of a new Opdivo® (nivolumab) subcutaneous formulation developed with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme...Read more


Bristol Myers Squibb Receives European Commission Approval for the Subcutaneous Formulation of Opdivo® (nivolumab) Across Multiple Solid Tumor Indications

May 28
Last Trade: 47.18 0.30 0.64

Opdivo is the first and only PD-1 inhibitor approved for subcutaneous (SC) use in the European Union Approval is based on results from the Phase 3 CheckMate -67T clinical trial which demonstrated noninferiority in the co-primary endpoints of Cavgd28 and Cminss, and consistent efficacy in the secondary endpoint of overall response rate, for the subcutaneous formulation of Opdivo (Opdivo SC) vs. its intravenous formulation (IV...Read more


Autolus Therapeutics Announces Positive CHMP Opinion for Obecabtagene Autoleucel for Adult Patients (age 26 and older) with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)

May 23
Last Trade: 1.50 -0.07 -4.46

Positive CHMP opinion based on FELIX clinical trial of obecabtagene autoleucel (obe-cel) in adult patients with r/r B-ALL, demonstrating high and durable response rates and low toxicity Opinion follows FDA approval and MHRA conditional marketing authorisation European Commission (EC) decision on conditional marketing authorization application (MAA) expected within approximately two months LONDON, May 23, 2025 (GLOBE NEWSWIRE) --...Read more


SpringWorks Therapeutics Receives Positive CHMP Opinion for Mirdametinib for the Treatment of Adult and Pediatric Patients with NF1-PN

May 23
Last Trade: 46.99 0.00 0.00

If approved, mirdametinib is expected to be the first and only therapy in the European Union with marketing authorization for both adults and children with NF1-PN Decision from European Commission expected in the third quarter of 2025 STAMFORD, Conn., May 23, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today...Read more


Soleno Therapeutics Announces Submission and EMA Validation of Marketing Authorization Application for Diazoxide Choline Prolonged-Release Tablets for the Treatment of Hyperphagia in Patients with Prader-Willi Syndrome

May 22
Last Trade: 67.67 -0.74 -1.08

REDWOOD CITY, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that Soleno’s Marketing Authorization Application (MAA) seeking regulatory approval of Diazoxide Choline Prolonged-Release Tablets (previously referred to as DCCR) for the treatment of adults and children four years and older...Read more


Quoin Pharmaceuticals Announces European Medicines Agency (EMA) Grants Orphan Drug Designation for QRX003 for the Treatment of Netherton Syndrome

May 20
Last Trade: 7.38 -0.12 -1.60

Company continues to advance QRX003 in late-stage clinical trials in Netherton Syndrome patients Regulatory milestone provides 10 years of market exclusivity in Europe upon approval ASHBURN, Va., May 20, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a late clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, today announces that it has been granted...Read more


Bristol Myers Squibb Receives European Commission Approval for Perioperative Regimen of Neoadjuvant Opdivo® (nivolumab) and Chemotherapy Followed by Adjuvant Opdivo for Resectable, High-Risk Non-Small Cell Lung Cancer with PD-L1 Expression ≥1%

May 16
Last Trade: 47.18 0.30 0.64

Approval based on results from the CheckMate-77T trial which showed perioperative Opdivo improved event-free survival compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo Opdivo is now the only PD-(L)1 inhibitor approved for both perioperative and neoadjuvant-only treatment of resectable non-small cell lung cancer in the European Union PRINCETON, N.J. / May 16, 2025 / Business Wire / Bristol Myers...Read more


Moleculin Biotech Receives European Medicines Agency Approval to Expand Phase 3 MIRACLE Clinical Trial

May 12
Last Trade: 0.39 -0.0011 -0.28

Adds nine additional countries to the Company’s ongoing pivotal Phase 3 trial; Authorization granted in all EU countries requested Enrollment and dosing underway in Phase 3 clinical trial (the “MIRACLE” trial) evaluating Annamycin for the treatment of R/R AML; Interim data readout expected in the second half of 2025 Subjects targeted for the “MIRACLE” trial include venetoclax regimen failures where outcomes with currently available...Read more


Biodexa Pharmaceuticals Receives Orphan Drug Designation in Europe for eRapa in FAP

May 12
Last Trade: 5.54 0.07 1.28

New designation follows the U.S. Food and Drug Administration (FDA) Orphan Drug Designation for eRapa in FAP granted in 2019 Company nears start of Registrational Phase 3 study targeted at an addressable market of $7.3Bn May 12, 2025 - Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with...Read more


Intensity Therapeutics and The Swiss Group for Clinical Cancer Research SAKK Receive European Medicines Agency Authorization to Initiate Phase 2 INVINCIBLE-4 (SAKK/66/22) Study for INT230-6 in the Treatment of Presurgical Triple-Negative Breast Canc

May 6
Last Trade: 0.29 -0.006 -2.06

INVINCIBLE-4 (SAKK/66/22) Study continues to recruit patients in eight sites in Switzerland SHELTON, Conn. and BERN, Switzerland, May 6, 2025 /PRNewswire/ -- Intensity Therapeutics, Inc. (Nasdaq: INTS), ("Intensity" or "the Company") a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune...Read more


CSL Vifor and Travere Therapeutics announce standard EU approval for FILSPARI® in IgA Nephropathy

April 29
Last Trade: 17.50 -0.20 -1.13

European Commission converts conditional approval of FILSPARI (sparsentan) into standard marketing authorization for the treatment of IgA Nephropathy (IgAN) Decision follows positive recommendation from Committee for Medicinal Products for Human Use (CHMP) from February 2025 EU approval is based on the complete data set from the phase-III PROTECT study ST. GALLEN, Switzerland and SAN DIEGO, April 29, 2025 /CNW/ -- CSL Vifor...Read more


Alnylam Pharmaceuticals Receives Positive CHMP Opinion for Vutrisiran for the Treatment of ATTR Amyloidosis with Cardiomyopathy

April 28
Last Trade: 446.51 -5.82 -1.29

Recommended Approval Based on the Pivotal HELIOS-B Phase 3 Study in which Vutrisiran Demonstrated Significant Reductions in Mortality and Cardiovascular Events, While Preserving Functional Status and Quality of Life  Offers a Clinically Differentiated Approach with Rapid and Sustained Transthyretin (TTR) Knockdown and Quarterly Subcutaneous Dosing  Follows Recent Approvals in the U.S. and Brazil  European Commission...Read more


Halozyme Therapeutics Announces argenx Received Positive CHMP Opinion for VYVGART® (efgartigimod alfa) Subcutaneous Injection with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

April 28
Last Trade: 73.15 0.34 0.47

European Commission (EC) decision on marketing authorization application expected within approximately two months SAN DIEGO, April 28, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that argenx received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending European Commission (EC) approval of VYVGART® 1000mg...Read more


Regeneron Pharmaceuticals: Lynozyfic™ (linvoseltamab) Approved in the European Union for the Treatment of Relapsed/Refractory Multiple Myeloma

April 28
Last Trade: 580.70 1.09 0.19

Approval of Lynozyfic is based on data showing deep and durable responses in relapsed/refractory multiple myeloma Lynozyfic will provide a new option with convenient dosing and administration to patients who face cycles of relapse and remission TARRYTOWN, N.Y., April 28, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Commission (EC) has granted conditional marketing...Read more


Krystal Biotech Announces European Commission Approval of VYJUVEK® for the Treatment of Dystrophic Epidermolysis Bullosa

April 28
Last Trade: 147.70 -2.84 -1.89

VYJUVEK approved for the treatment of DEB from birth in Europe Approval allows for dosing at home or in a healthcare setting, as well as patient or caregiver administration if deemed appropriate by a healthcare professional PITTSBURGH, April 28, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced today that on April 23, 2025, the European Commission (EC) granted marketing authorization to VYJUVEK®...Read more


argenx Announces Positive CHMP Opinion for VYVGART (efgartigimod alfa) Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

April 28
Last Trade: 712.20 7.27 1.03

VYVGART® is first-and-only targeted IgG Fc-antibody fragment for CIDP First novel mechanism of action for CIDP treatment in more than 30 years CHMP positive opinion based on ADHERE data, the largest ever CIDP clinical trial European Commission (EC) decision on marketing authorization application (MAA) expected within approximately two months April 28, 2025, 07:00 AM CET - Amsterdam, the Netherlands – argenx SE (Euronext...Read more


SpringWorks Therapeutics Announces Expected CHMP Opinion in Q2 2025 for Nirogacestat for the Treatment of Adults with Desmoid Tumors in the European Union

April 27
Last Trade: 46.99 0.00 0.00

STAMFORD, Conn., April 27, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the Company anticipates the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) will adopt an opinion on the marketing authorization application (MAA) for nirogacestat, an oral gamma secretase...Read more


Jazz Pharmaceuticals Receives CHMP Positive Opinion for Zanidatamab for the Treatment of Advanced HER2-Positive Biliary Tract Cancer

April 25
Last Trade: 127.75 1.62 1.28

DUBLIN, April 25, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the conditional marketing authorization of zanidatamab, an investigational dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, as monotherapy for the treatment of...Read more


PTC Therapeutics Receives Positive CHMP Opinion for Sephience™ (sepiapterin) for the Treatment of Children and Adults Living with Phenylketonuria (PKU)

April 25
Last Trade: 49.33 -0.46 -0.92

Label includes full spectrum of PKU patients European launch preparations underway WARREN, N.J., April 25, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on the marketing authorization application for Sephience™ (sepiapterin) for the treatment of children and adults living...Read more


Dyne Therapeutics Receives European Medicines Agency (EMA) Orphan Drug Designation for DYNE-251 in Duchenne Muscular Dystrophy

April 24
Last Trade: 13.49 -0.26 -1.89

Recently presented data demonstrated sustained functional improvement with DYNE-251 treatment through 18 months  Data from the fully enrolled DELIVER registrational expansion cohort is planned for late 2025  WALTHAM, Mass., April 24, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on advancing life-transforming therapeutics for people living with genetically driven...Read more


Cullinan Therapeutics Receives Approval from European Medicines Agency to Initiate Phase 1 Trial of CLN-978, a Bispecific CD19 T Cell Engager Administered Subcutaneously, in Patients with Rheumatoid Arthritis

April 16
Last Trade: 7.54 -0.07 -0.92

Company-sponsored clinical trial will be initiated at FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore, Rome in Q2 2025 CLN-978 is also being studied in the U.S., Europe, and Australia for systemic lupus erythematosus CAMBRIDGE, Mass., April 16, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies,...Read more


Biogen: Leqembi®∇ (lecanemab) is the First Medicine that Slows Progression of Early Alzheimer’s Disease to be Authorized in the European Union

April 15
Last Trade: 132.22 -0.43 -0.32

In the European Union (EU), lecanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (early AD) who are apolipoprotein E ε4 (ApoE ε4*) non-carriers or heterozygotes with confirmed amyloid pathology Lecanemab is the first therapy that targets an underlying cause of the disease to be authorized in the EU for eligible people with...Read more


Halozyme Therapeutics: European Commission Approved Subcutaneous DARZALEX® (daratumumab)-based Quadruplet Regimen for the Treatment of Patients with Newly Diagnosed Multiple Myeloma, Regardless of Transplant Eligibility

April 9
Last Trade: 73.15 0.34 0.47

Subcutaneous DARZALEX® is co-formulated with Halozyme's ENHANZE® drug delivery technology SAN DIEGO, April 9, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson & Johnson company, received European Commission (EC) approval for an indication extension of DARZALEX® (daratumumab) subcutaneous (SC) co-formulated with ENHANZE® in the frontline...Read more


AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Adults with Giant Cell Arteritis

April 8
Last Trade: 210.40 2.48 1.19

RINVOQ is the first and only oral Janus kinase (JAK) inhibitor approved in the European Union (EU) to treat adult patients with giant cell arteritis (GCA) The approval is supported by data from the pivotal Phase 3 SELECT-GCA trial which demonstrated that RINVOQ achieved the primary endpoint of sustained remission* and key secondary endpoints, including reduction in disease flares, lower cumulative steroid exposure and complete...Read more


Akebia Therapeutics Announces Positive Opinion of European Medicines Agency for XOANACYL®, an Oral Therapy for Chronic Kidney Disease Licensed to Averoa

April 3
Last Trade: 3.14 0.01 0.32

CAMBRIDGE, Mass., April 03, 2025 (GLOBE NEWSWIRE) -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the European Commission (EC) to approve XOANACYL® (Ferric Citrate as Coordination...Read more


Pharvaris Announces Orphan Designation Granted to Deucrictibant by the European Commission

April 1
Last Trade: 21.65 -1.19 -5.21

ZUG, Switzerland, April 01, 2025 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to help address unmet needs of those living with bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), today announced that the European Commission (EC) has granted orphan designation to...Read more


European Commission Approves Pfizer’s RSV Vaccine ABRYSVO® to Help Protect Adults Aged 18-59 Against RSV Lower Respiratory Tract Disease

April 1
Last Trade: 24.76 0.16 0.65

ABRYSVO is the first and only RSV vaccine approved in the European Union (EU) for non-pregnant adults aged 18-49 NEW YORK / Apr 01, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has issued a decision amending the marketing authorization for ABRYSVO®, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to extend the indication to include prevention of...Read more


Genmab: TIVDAK® (tisotumab vedotin) Approved by European Commission for Previously Treated Recurrent or Metastatic Cervical Cancer

March 31
Last Trade: 24.87 -0.24 -0.96

TIVDAK® is the first and only antibody-drug conjugate (ADC) approved to treat recurrent or metastatic cervical cancer with disease progression on or after systemic therapy In the global Phase 3 innovaTV 301 clinical trial TIVDAK demonstrated superior overall survival compared to chemotherapy TIVDAK is approved for the treatment of recurrent or metastatic cervical cancer in the European Union, United States and Japan COPENHAGEN,...Read more


Halozyme Therapeutics Announces Bristol Myers Squibb Received Positive CHMP Opinion for the Subcutaneous Formulation of Opdivo® (nivolumab) with ENHANZE® Across Multiple Solid Tumor Indications

March 31
Last Trade: 73.15 0.34 0.47

A decision on the European marketing authorization extension for the subcutaneous formulation of Opdivo is expected by June 2, 2025 SAN DIEGO, March 31, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Bristol Myers Squibb received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, recommending approval of a new Opdivo®...Read more


BeiGene Receives Positive CHMP Opinion for TEVIMBRA® as a First-Line Treatment for Extensive-Stage Small Cell Lung Cancer

March 31
Last Trade: 184.71 0.00 0.00

Positive opinion for first-line treatment of extensive-stage small cell lung cancer based on results of RATIONALE-312 study demonstrating statistically significant overall survival benefit for TEVIMBRA in combination with chemotherapy SAN CARLOS, Calif. / Mar 31, 2025 / Business Wire / BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today...Read more


PTC Therapeutics Provides Regulatory Update on Translarna™ (ataluren) in Europe

March 28
Last Trade: 49.33 -0.46 -0.92

WARREN, N.J., March 28, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the European Commission (EC) has adopted the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) to not renew the authorization of Translarna™ (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy. While this action effectively removes the drug's...Read more


Bristol Myers Squibb Receives Positive CHMP Opinion for Perioperative Regimen of Neoadjuvant Opdivo® (nivolumab) and Chemotherapy Followed by Surgery and Adjuvant Opdivo for Resectable Non-Small Cell Lung Cancer in Patients with Tumor Cell PD-L1...

March 28
Last Trade: 47.18 0.30 0.64

Recommendation based on Phase 3 CheckMate -77T trial showing significant event-free survival improvement when compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo If approved by the European Commission, the perioperative regimen would be the company’s second Opdivo-based regimen available for the treatment of resectable non-small cell lung cancer in the European Union PRINCETON, N.J. / Mar 28, 2025...Read more


Bristol Myers Squibb Receives Positive CHMP Opinion for the Subcutaneous Formulation of Opdivo® (nivolumab) Across Multiple Solid Tumor Indications

March 28
Last Trade: 47.18 0.30 0.64

Recommendation is based primarily on results from the Phase 3 CheckMate -67T trial which demonstrated noninferiority in the co-primary endpoints of Cavgd28 and Cminss and consistent efficacy in the secondary endpoint of overall response rate for the subcutaneous formulation of Opdivo vs. its intravenous formulation A decision on the EU Opdivo extension of marketing authorization is expected by June 2, 2025 PRINCETON, N.J. / Mar 28,...Read more


European Medicines Agency (EMA) Validates Henlius and Organon Filing for Perjeta® (pertuzumab) Biosimilar Candidate HLX11

March 28
Last Trade: 9.42 0.24 2.61

SHANGHAI, China & JERSEY CITY, N.J. / Mar 28, 2025 / Business Wire / Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for HLX11, an investigational biosimilar of Perjeta® (pertuzumab). Pertuzumab has been approved in various countries and regions in combination with trastuzumab and chemotherapy for the...Read more


Crinetics Pharmaceuticals Announces European Medicines Agency (EMA) Validation of Marketing Authorization Application (MAA) and Orphan Drug Designation (ODD) for Paltusotine in Acromegaly

March 27
Last Trade: 30.99 0.34 1.11

SAN DIEGO, March 27, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for paltusotine, the first once-daily, oral, selectively-targeted somatostatin receptor type 2 nonpeptide agonist, for the proposed treatment and long-term maintenance therapy of acromegaly, a serious, rare and progressive endocrine...Read more


European Commission (EC) Approves Merck’s CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults

March 26
Last Trade: 84.12 0.91 1.09

EC decision marks the fourth approval for CAPVAXIVE for pneumococcal vaccination in adults RAHWAY, N.J. / Mar 26, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the European Commission (EC) has approved CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae...Read more


Bristol Myers Squibb Receives Approval from the European Commission to Expand Use of CAR T Cell Therapy Breyanzi for Relapsed or Refractory Follicular Lymphoma

March 14
Last Trade: 47.18 0.30 0.64

In the TRANSCEND FL trial, 97.1% of patients responded to Breyanzi, with 94.2% of patients achieving complete response* Breyanzi demonstrated sustained clinical benefit, with 75.7% of patients still in response at 18 months, and a consistent safety profile with no new safety signals observed PRINCETON, N.J. / Mar 14, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has granted...Read more


Geron Announces European Commission Approval of RYTELO® (imetelstat), a First-in-Class Telomerase Inhibitor, for the Treatment of Adults With Transfusion-Dependent Anemia Due to Lower-Risk MDS

March 11
Last Trade: 1.40 -0.03 -2.10

Approval across ESA ineligible and ESA relapsed/refractory non-del 5q patients with transfusion-dependent anemia due to LR-MDS, regardless of ring sideroblast (RS) status RYTELO is the first and only telomerase inhibitor approved in the U.S. and Europe FOSTER CITY, Calif. / Mar 11, 2025 / Business Wire / Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of...Read more


Ionis Pharmaceuticals: WAINZUA (eplontersen) approved in the EU for the treatment of hereditary transthyretin-mediated amyloidosis in adults with stage 1 or stage 2 polyneuropathy

March 10
Last Trade: 42.64 0.02 0.05

Second major approval for WAINZUA, which is marketed in the U.S. as WAINUA™  EU approval based on NEURO-TTRansform Phase 3 results showing WAINZUA demonstrated consistent and sustained benefit improving neuropathy impairment and quality of life versus placebo CARLSBAD, Calif. / Mar 10, 2025 / Business Wire / Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that Ionis and AstraZeneca’s WAINZUA (eplontersen) has been...Read more


Ocugen Announces Positive Opinion of EMA’s Committee for Advanced Therapies for ATMP Classification for Novel Modifier Gene Therapy Candidate OCU410 for Geographic Atrophy and OCU410ST for Stargardt Disease

March 3
Last Trade: 1.02 -0.03 -2.86

MALVERN, Pa., March 03, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the European Commission has provided a positive opinion from the European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) for OCU410 and OCU410ST Advanced Therapy Medicinal Product (ATMP) classification. OCU410 is a novel,...Read more


Biogen: The Committee for Medicinal Products for Human Use (CHMP) Reaffirms Positive Opinion for Lecanemab in Early Alzheimer's Disease

February 28
Last Trade: 132.22 -0.43 -0.32

TOKYO and CAMBRIDGE, Mass., Feb. 28, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has reaffirmed its positive opinion by consensus for the anti-Aβ monoclonal...Read more


Eli Lilly's Jaypirca (pirtobrutinib) recommended by CHMP for approval in the European Union for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) previously treated with a BTK inhibitor

February 28
Last Trade: 732.58 0.62 0.08

The positive opinion is based on results from the Phase 3 BRUIN CLL-321 trial, recently presented at the 2024 American Society of Hematology Annual Meeting  BRUIN CLL-321 is the first randomized Phase 3 study in CLL ever conducted exclusively in patients previously treated with a BTK inhibitor INDIANAPOLIS, Feb. 28, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency's (EMA)...Read more


Krystal Biotech Receives Positive CHMP Opinion for VYJUVEK® for the Treatment of Dystrophic Epidermolysis Bullosa

February 28
Last Trade: 147.70 -2.84 -1.89

PITTSBURGH, Feb. 28, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today welcomed the European Medicines Agency's (EMA’s) announcement that its Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for the European Commission (EC) to approve VYJUVEK® (beremagene geperpavec-svdt, or B-VEC) for the treatment of wounds in...Read more


Regeneron Pharmaceuticals: Linvoseltamab Recommended for EU Approval by the CHMP to Treat Relapsed/Refractory Multiple Myeloma

February 28
Last Trade: 580.70 1.09 0.19

TARRYTOWN, N.Y., Feb. 28, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of linvoseltamab to treat adults with relapsed and refractory (R/R) multiple myeloma (MM). The recommendation is specific to those who have received at...Read more


AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults with Giant Cell Arteritis

February 28
Last Trade: 210.40 2.48 1.19

The positive opinion is based on results from the pivotal Phase 3 SELECT-GCA trial that evaluated the efficacy and safety of upadacitinib in adults with giant cell arteritis (GCA)1 The primary endpoint of sustained remission* and key secondary endpoints, including reduction in disease flares, lower cumulative steroid exposure, and complete remission,† were met1   GCA is an autoimmune disease that causes...Read more


European Medicines Agency Validates Gilead Sciences’ Marketing Authorization Application and EU-Medicines for All Application for Twice-Yearly Lenacapavir for HIV Prevention

February 24
Last Trade: 113.08 0.52 0.46

One Application Seeks European Commission Authorization; Other Application Would Facilitate Availability in Low- and Lower-Middle-Income Countries  Both Applications Will Be Assessed in Parallel Under Accelerated Assessment Review Timeline Based on Potential Public Health Interest in Lenacapavir for HIV Prevention EMA Validation Follows Acceptance of U.S. Applications by FDA Under Priority Review  FOSTER CITY, Calif. / Feb...Read more


Takeda: The European Medicines Agency (EMA) Has Approved an Additional Subcutaneous Administration Option for TAKHZYRO® (lanadelumab) for Patients Aged 12 Years and Above with Recurrent Attacks of Hereditary Angioedema (HAE)

February 24
Last Trade: 14.99 0.02 0.13

TAKHZYRO Solution for Injection in 2 mL Pre-Filled Pen is Now Approved to Facilitate Subcutaneous Administration in Adolescent (Aged 12 Years and Above) and Adult Patients with HAE.1 The Pre-Filled Pen Option is Designed to Allow for An Individualized Treatment Approach for Adolescent and Adult HAE Patients. In the EU, TAKHZYRO is Approved for Routine Prevention of Recurrent HAE Attacks in Patients Aged 2 Years and Older.1 ZURICH,...Read more


Apellis Pharmaceuticals and Sobi Announce EMA Validation of Indication Extension Application for Aspaveli® (pegcetacoplan) for C3G and Primary IC-MPGN

February 20
Last Trade: 27.57 -0.48 -1.71

WALTHAM, Mass. and STOCKHOLM, Sweden, Feb. 20, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Sobi® (STO:SOBI) today announced the European Medicines Agency (EMA) has validated an indication extension application for Aspaveli® (pegcetacoplan) for the treatment of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), which are rare, chronic kidney...Read more


European Commission Approves CSL and Arcturus Therapeutics’ KOSTAIVE®, the First Self-amplifying mRNA COVID-19 Vaccine

February 14
Last Trade: 17.01 -0.29 -1.68

KOSTAIVE represents a significant advancement in vaccine technology, demonstrating superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines in clinical trials WALTHAM, Mass. & SAN DIEGO / Feb 14, 2025 / Business Wire / Global biotechnology leader CSL (ASX: CSL; USOTC: CSLLY) and sa-mRNA pioneer Arcturus Therapeutics (Nasdaq: ARCT) today announced that the...Read more


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