Advances European commercialization strategy following CE mark approval ATLANTA, Aug. 20, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced that it received the Medicines and Healthcare products Regulatory Agency (MHRA) approval for its FemBloc Permanent Birth Control, which...Read more
AUSTIN, Aug. 19, 2025 (GLOBE NEWSWIRE) -- Rein Therapeutics ("Rein") (NASDAQ: RNTX), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has authorized the Company to initiate its Phase 2 “RENEW” clinical trial of LTI-03, the...Read more
MHRA seeks to harmonize UK & US regulatory review via Project Orbis EMA Rapporteur Scientific Advice Meeting scheduled for October 2025 New York, New York--(Newsfile Corp. - August 7, 2025) - OS Therapies (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that it held a successful Scientific Advice Meeting with the...Read more
MHRA indicated ART12.11 may be a candidate for accelerated development via the Innovative Licensing and Access Pathway SOLANA BEACH, Calif., Aug. 01, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (“Artelo” or the “Company”) (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatologic, or neurological...Read more
EURneffy (neffy® in the U.S.) offers a new delivery method for adrenaline in the U.K. for adults and children (>30 kg) living with severe allergic reactions ALK-Abelló A/S, which owns the rights to market EURneffy in the U.K., expects availability in late Q3 2025 U.K. is the largest market outside the U.S. for adrenaline (epinephrine) auto-injector sales SAN DIEGO, July 18, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc....Read more
EMBRACE, the second Phase 3 study within the PARADIGM program, expects to enroll 330 participants at approximately 60 clinical sites across the United States, Europe and Australia and will commence imminently PARADIGMTM comprises two 12-week randomized, double-blind, placebo-controlled studies (APPROACH® and EMBRACE®) and a long-term extension study (EXTEND), with anticipated combined enrollment of approximately 550 participants Dosing...Read more
EKTERLY to be added to the Orphan Register and awarded 10 years of market exclusivity CAMBRIDGE, Mass. & SALISBURY, England / Jul 15, 2025 / Business Wire / KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) has granted marketing authorization for EKTERLY® (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment...Read more
The first approval worldwide for elinzanetant, under the brand name LynkuetTM (Lynkuet®* in the UK), for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause is based on results from the three pivotal trials in the OASIS Phase III clinical development program1 / Elinzanetant is the first dual neurokinin (NK)-targeted therapy (NK-1 and NK-3 receptor antagonist) and has...Read more
ANKTIVA, a first-in-class, lymphocyte-stimulating agent, works synergistically with BCG to activate and proliferate natural killer (NK) and T cells, helping eliminate cancer Already approved in the U.S. and designated as a Breakthrough Therapy by the FDA, this marks ANKTIVA’s first marketing approval outside the U.S. ANKTIVA plus BCG offers a new option for eligible patients among the 16,400 to 18,000 people diagnosed with NMIBC in the...Read more
The UK approval is based on positive results from the Phase 3 ATTRibute-CM study, in which acoramidis demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date In as few as 3 months, the time to first event (all-cause mortality (ACM) or cardiovascular-related hospitalization (CVH)) durably separated relative to placeboA 42% reduction in composite ACM and recurrent CVH events relative to placebo at Month 30A 50%...Read more
UK Medicines and Healthcare products Regulatory Agency (MHRA) authorisation based on FELIX clinical trial of obecabtagene autoleucel in adult patients with r/r B-ALL1 AUCATZYL® licensed from MHRA under ‘conditional marketing authorisation’, meaning that the MHRA will review new efficacy and safety information at least once every year1 LONDON, April 25, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early...Read more
BOULDER, CO / ACCESS Newswire / April 22, 2025 / Sonoma Pharmaceuticals, Inc. (Nasdaq:SNOA), a global healthcare leader developing and producing patented Microcyn® technology based stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care, eye, oral and nasal care, dermatological conditions, podiatry, and animal health care, today announced the registration of its hypochlorous acid-based acne...Read more
REYKJAVIK, Iceland, PISCATAWAY, N.J. and LONDON, March 26, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacturing of biosimilar medicines for patients worldwide, Kashiv Biosciences LLC (“Kashiv”), a fully integrated biopharmaceutical company headquartered in New Jersey, US, and Advanz Pharma, a UK-headquartered global pharmaceutical company with a strategic focus...Read more
BOULDER, CO / ACCESS Newswire / March 10, 2025 / Sonoma Pharmaceuticals, Inc. (Nasdaq:SNOA), a global healthcare leader developing and producing patented Microcyn® technology based stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care, eye, oral and nasal care, dermatological conditions, podiatry, and animal health care, today announced the registration of its manufacturing facility and five...Read more
mRESVIA® is Moderna's second approved product in the UK CAMBRIDGE, MA / ACCESS Newswire / February 28, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has granted marketing authorization for mRESVIA (mRNA-1345), indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in...Read more
CULVER CITY, Calif. / Feb 13, 2025 / Business Wire / ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunity therapy company, today announced the Medicines and Healthcare products Regulatory Agency (MHRA) has validated and accepted the marketing authorization application for ANKTIVA. The MHRA will now begin assessing the marketing authorization application (MAA) for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with bacillus...Read more
MELBOURNE, Australia, Feb. 13, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the Marketing Authorization Application (MAA) for its prostate cancer PET1 imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection). Illuccix is indicated in the UK...Read more
ATLANTA, Feb. 11, 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, announces the receipt of the Medicines & Healthcare products Regulatory Agency (MHRA) approvals for the FemaSeed® Intratubal Insemination product for female infertility...Read more
Company on track to initiate ELEVATE-44-201 in Q2 2025 ENTR-601-44 regulatory filings submitted in additional geographies including the U.S. and EU, with regulatory discussions ongoing BOSTON, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today announced it had received authorization from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics...Read more
Marketing authorization application for BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) with Carcinoma in situ (CIS) submitted to European Medicines Agency (EMA) in December 2024 and anticipated acceptance of application in 2025 Marketing authorization application for BCG Unresponsive NMIBC CIS submitted to United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) in November 2024 and anticipated acceptance...Read more
REC-3565 is a potential best-in-class MALT1 inhibitor for multiple hematology indications, designed to reduce the risk of hyperbilirubinemia, a common side effect of other MALT1 inhibitors REC-4539, a potential best-in-class LSD1 inhibitor, is the first designed to be reversible and CNS penetrant for small-cell lung cancer Salt Lake City, UT, Jan. 07, 2025 (GLOBE NEWSWIRE) -- Recursion (NASDAQ: RXRX), a leading clinical stage...Read more
IMDYLLTRA® is indicated for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after at least two prior lines of therapy, including platinum-based chemotherapy1 Lung cancer is the third most common cancer in the UK, with more than 49,000 cases diagnosed in the UK between 2017 and 20192 Small cell lung cancer (SCLC) accounts for approximately 15% of all lung cancers3 In...Read more
Canada and United Kingdom represent two of the largest markets within the ALK portfolio with plans to expand filings of neffy (epinephrine nasal spray) 2 mg in other key global regions SAN DIEGO, Jan. 06, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to...Read more
Innovation Passport Designation Aims to Accelerate Time to Market and Facilitate Patient Access to Innovative Medicines NEW YORK / Dec 05, 2024 / Business Wire / Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (the "Company" or "MindMed"), a clinical-stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced that MM120 ODT, a pharmaceutically optimized form of lysergide...Read more
BOSTON, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that the United Kingdom’s Medicines & Healthcare products Regulatory Agency (MHRA) has expanded the marketing authorization for IMCIVREE® (setmelanotide) to include the treatment of obesity...Read more
Great Britain is the third major market where donanemab has received approval Donanemab was first approved in the United States in July 2024 and then approved in Japan in September 2024 INDIANAPOLIS, Oct. 23, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for donanemab, an injection for intravenous infusion...Read more
VIENNA, Va. / Sep 04, 2024 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today reported it has received a decision letter from the United Kingdom’s Healthcare Products Regulatory Agency (MHRA) granting Multikine (Leukocyte Interleukin, Injection)* a product specific waiver for the treatment of head and neck cancer in a pediatric population of people up to 18 years of age. As a result, CEL-SCI will not be required to evaluate...Read more
Approval follows recommendation from global public health bodies to develop JN.1 COVID-19 vaccines At present, the JN.1 group of subvariants remain dominant in the UK The updated vaccine will be available for eligible groups as part of the NHS autumn vaccination program, and will also be available to purchase privately in the UK for the first time CAMBRIDGE, MA / ACCESSWIRE / September 3, 2024 / Moderna, Inc. (Nasdaq:MRNA) today...Read more
In Great Britain, lecanemab is indicated for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease (AD) in adult patients that are apolipoprotein E ε4 (ApoE ε4)* heterozygotes or non-carriers1 Great Britain becomes the first country in Europe to authorize the medicine, which targets an underlying cause of AD1 TOKYO and CAMBRIDGE, Mass., Aug. 22, 2024 /PRNewswire/ -- Eisai Co., Ltd....Read more
Award recognizes the potential for INO-3107 to be the first therapeutic option in the United Kingdom for patients suffering from Recurrent Respiratory Papillomatosis (RRP) PLYMOUTH MEETING, Pa., July 11, 2024 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced...Read more
UK MHRA marketing authorization follows recent European Commission Marketing Authorization for LYTENAVA™ (bevacizumab gamma) in the EU for the treatment of wet AMD Initial commercial launches of LYTENAVA™ (bevacizumab gamma) in the EU and UK anticipated in calendar Q1 2025 Strategic partnership with Cencora (formerly AmerisourceBergen) to support the planned commercial launches of LYTENAVA in UK and EU ISELIN, N.J., July 08, 2024...Read more
UK submission for national MAA review follows recently received positive opinion from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) concerning the authorization of ONS-5010/LYTENAVA™ (bevacizumab gamma) ISELIN, N.J., May 13, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve regulatory approval for the first authorized use...Read more
COPENHAGEN, Denmark, April 24, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the United Kingdom’s Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for YORVIPATH® (palopegteriparatide; developed as TransCon™ PTH) in Great Britain as a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism, and has...Read more
CAMBRIDGE, Mass., March 26, 2024 (GLOBE NEWSWIRE) -- Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today announced the clearance of its clinical trial authorisation (CTA) application by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency for BEAM-302, an in vivo base editor, as a potential treatment for patients with alpha-1 antitrypsin...Read more
CHICAGO, IL / ACCESSWIRE / March 19, 2024 / Cosmos Health Inc. ("Cosmos Health" or the "Company'') (NASDAQ:COSM), a diversified, vertically integrated global healthcare group engaged in innovative R&D, owner of proprietary pharmaceutical and nutraceutical brands, manufacturer and distributor of healthcare products, and operator of a telehealth platform, announced today it is in the final stages of securing regulatory approval to sell...Read more
LONDON, March 12, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that following the most recent GMP inspection by the MHRA in February 2024, Autolus’ Nucleus manufacturing facility in Stevenage has obtained a Manufacturer’s Importation Authorisation (MIA) together with the accompanying GMP certificate....Read more
Full EAMS designation would allow treatment of patients with sebetralstat prior to receiving a Marketing Authorization from UK CAMBRIDGE, Mass. & SALISBURY, England / Mar 12, 2024 / Business Wire / KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today announced the UK Medicines and...Read more
BOSTON, March 04, 2024 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has authorized its Clinical Trial Application (CTA) to initiate the CONNECT2-EDO51 Phase...Read more
Increases dose level in line with Cohort 2 in IND Changes from "in patient" to "out patient" procedure EDINBURGH, Scotland, Feb. 22, 2024 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, today announced that the MHRA has officially accepted its proposed...Read more
Provides entry to UK Innovative Licensing and Access Pathway (ILAP), which aims to accelerate time to market and facilitate patient access to innovative medicines Late-breaking sebetralstat phase 3 data to be presented at the upcoming 2024 American Academy of Allergy, Asthma & Immunology Annual Meeting CAMBRIDGE, Mass. & SALISBURY, England / Feb 20, 2024 / Business Wire / KalVista Pharmaceuticals, Inc. (NASDAQ:...Read more
The UK MHRA approval follows approvals by the U.S. FDA and the European Commission Cidara is entitled to receive a milestone payment of approximately $2.8 million from Mundipharma SAN DIEGO, Jan. 29, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing therapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced that the...Read more
DALLAS, Jan. 29, 2024 (GLOBE NEWSWIRE) -- Spectral MD, Inc. (“SMD”), a subsidiary of Spectral AI, Inc. (NASD: MDAI; MDAIW) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced the submission of an application in the United Kingdom for its predictive software DeepView AI®-Burn to be registered as UK Conformity...Read more
REDWOOD CITY, Calif., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has awarded the innovative medicine designation, the Innovation Passport, to RZ358 for the treatment of...Read more
Culmination Of Over 20 Years Of Research And Clinical Development BETHESDA, Md., Dec. 21, 2023 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that a Marketing Authorization Application (MAA) was submitted yesterday to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK for DCVax®-L...Read more
First regulatory authorization of a CRISPR-based gene-editing therapy in the world CASGEVY is indicated for the treatment of sickle cell disease in patients 12 years of age and older with recurrent vaso-occlusive crises who have the βS/βS, βS/β+ or βS/β0 genotype, for whom hematopoietic stem cell transplantation is appropriate and a human leukocyte antigen matched related hematopoietic stem cell donor is not...Read more
SAN DIEGO and ZUG, Switzerland, Nov. 3, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX), a commercial stage biotechnology company, today announced the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) granted conditional marketing authorization approval for KRAZATI® (adagrasib) as a monotherapy indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with...Read more
BOTHELL, Wash., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (Cocrystal or the Company) announces receipt of authorization from the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) to initiate a Phase 2a human challenge trial with its broad-spectrum, oral PB2 inhibitor CC-42344 as a potential treatment for pandemic and seasonal influenza A. Cocrystal expects to begin treating...Read more
CEL-SCI will present the MHRA with new results that demonstrate pre-surgical response rates and overall survival advantages that are superior to those published by CEL-SCI previously, as a result of an improved selection algorithm that more accurately predicts the patients who would benefit most from the Multikine therapy UK has about 12,500 new head & neck cancer cases each year VIENNA, Va. / Oct 05, 2023 / Business Wire /...Read more
STOCKHOLM, Oct. 3, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) ("Calliditas") today announced that its partner STADA Arzneimittel AG ("STADA") has submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the conditional marketing authorization for Kinpeygo®, a treatment for primary IgA nephropathy (IgAN), to standard, or "full",...Read more
VANCOUVER, British Columbia, July 20, 2023 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:PMBHF), a biotechnology company focused on the research, development, and manufacturing of novel MDXX class molecules (including MDMA), is thrilled that – following pre-submission meetings held in Q1 of 2023 – it has received written guidance from the UK’s Medicines and Healthcare products Regulatory...Read more
In January 2023, the company had announced the successful completion of the full set of clinical studies of its proposed rituximab biosimilar candidate DRL_RI, with the intention to file in the United States, European Union and other regions Following dossier submission in April 2023, the regulatory agencies have now accepted the dossier for review HYDERABAD, India / Jul 12, 2023 / Business Wire / Dr. Reddy’s Laboratories Ltd....Read more
CAMBRIDGE, Mass., May 22, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA) today announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Vafseo® (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the treatment of symptomatic anemia associated with chronic kidney disease (CKD) in adults on chronic...Read more
LONDON, May 22, 2023 (GLOBE NEWSWIRE) -- Freeline Therapeutics Holdings plc (Nasdaq: FRLN) today announced that FLT201 has been awarded the Innovation Passport for the treatment of Gaucher disease type 1 under the Innovative Licensing and Access Pathway (ILAP) process by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA). The Innovation Passport is the first step in the ILAP process, which in collaboration with MHRA and...Read more
Third generation drug substance manufacturing process increases the final yield of nomacopan by at least 5-fold, improving cost efficiencies in the continuing Phase 3 clinical trial of nomacopan in pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA) advancing to pivotal Part B later this year NEW YORK and LONDON, March 29, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a...Read more
VYVGART is the first neonatal Fc receptor (FcRn) blocker approved in the UK for the treatment of adults living with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive 68% of anti-AChR antibody positive gMG patients treated with VYVGART were responders (n=44/65) on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale compared with 30% of patients treated with placebo (n=19/64)...Read more
UK MHRA scientific advice meeting deems RHB-102 (BEKINDA®) data supportive of submission for approval for chemotherapy and radiotherapy induced nausea and vomiting (CINV/RINV) RHB-102 UK Marketing Authorisation Application (MAA) submission planned for 2H/23 If approved for marketing by the MHRA, RHB-102 could become the first oral 24hr extended-release 5-HT3 antiemetic drug in the UK indicated for the treatment of...Read more
BOSTON, Feb. 14, 2023 (GLOBE NEWSWIRE) -- Verve Therapeutics, Inc., a clinical-stage biotechnology company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today announced that VERVE-101 has been awarded the Innovation Passport for the treatment of heterozygous familial hypercholesterolemia (HeFH) under the Innovative Licensing and Access Pathway (ILAP) by the Medicines and...Read more
STOCKHOLM, Feb. 2, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has granted Conditional Marketing Authorization (CMA) for Kinpeygo® for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a...Read more
MHRA marketing authorizations follow recent European Commission marketing authorizations BRUKINSA is the only treatment authorized for MZL in Great Britain BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorizations for BRUKINSA (zanubrutinib) in Great Britain for both the treatment of adult...Read more
Designation Marks Entry Point into MHRA's Innovative Licensing and Access Pathway (ILAP) Program in the UK DUBLIN, Jan. 17, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that nemvaleukin alfa (nemvaleukin), the company's investigational, novel engineered interleukin-2 (IL-2) variant immunotherapy, has been granted an Innovation Passport for the treatment of mucosal melanoma under the Innovative Licensing...Read more
PIP Approval Is A Pre-Requisite for Application for Approval of A New Medicine for Adult Patients Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the Company's Pediatric Investigation Plan (PIP). The...Read more
Study results show mRNA-1273.214 has demonstrated significantly higher antibody titers against Omicron BA.1 and BA.4/5 subvariants when compared with mRNA-1273 Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has granted conditional authorization for the use of the Omicron-containing...Read more
Chimerix is on a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company is devoted to filling gaps in the treatment paradigm. Chimerix’s most advanced clinical-stage program is in development for H3 K27M-mutant glioma....
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