Oral semaglutide (Rybelsus®) is now the first and only oral GLP-1 RA approved for type 2 diabetes, with proven cardiovascular benefits1 This approval is based on results from the SOUL clinical trial, where oral semaglutide (Rybelsus®) reduced cardiovascular death, heart attack and stroke by 14% versus placebo, when added to standard of care, in adults with type 2 diabetes at high cardiovascular risk1 In addition, new results from SOUL...Read more
PARSIPPANY, N.J. / Sep 12, 2025 / Business Wire / Zoetis Inc. today announced that the Committee for Veterinary Medicinal Products (CVMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of marketing authorization for Portela® (relfovetmab), a new monoclonal antibody (mAb) therapy intended for the alleviation of pain associated with osteoarthritis (OA) in cats. Portela Will Be First...Read more
Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor 1 Filing based on four Phase 3 studies that met all primary and co-primary endpoints. This unprecedented data package includes head-to-head superiority comparisons versus deucravacitinib, adolescent data, and evaluation of difficult to treat skin sites2,3,4,5,6 Submission underscores that icotrokinra has the potential to...Read more
NEW YORK, Sept. 10, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical innovator, today announced it has submitted its Clinical Trial Application (CTA) to the European Medicines Agency (EMA) to expand its ongoing Phase II trial of HT-001, a novel topical therapeutic for skin toxicities associated with Epidermal Growth Factor Receptor inhibitors (EGFRi). The submission marks a major...Read more
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 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
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
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
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
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
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
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
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
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
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
– 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
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