European Medicines Agency

Cullinan Therapeutics receives EMA approval for rheumatoid arthritis drug trial Clinical Trials Arena14:28Cullinan Therapeutics Arthritis Pharma

Accord receives positive EMA opinion for two denosumab biosimilars JD Supra17:29

Europe’s controversial quest for an Alzheimer’s drug EurActiv.com05:08

Eli Lilly’s Alzheimer’s drug not recommended by top European regulator WFYI Indianapolis21:29

Sarepta/Roche suspend elevidys gene therapy trials in Europe after patient death Benzinga20:41Biology

Aprogen becomes 1st Korean firm to drop phase 3 for faster EMA review Korea Biomedical Review08:48Biotech Biotechnology Pharma

Organon/Henlius announce EMA validation for Perjeta biosimilar HLX11 PMLiVE12:26Biotech Biotechnology Pharma

Latest News

In the last 7 days

Aprogen becomes 1st Korean firm to drop phase 3 for faster EMA review Korea Biomedical Review08:48 18-Apr-25

Cullinan Therapeutics receives EMA approval for rheumatoid arthritis drug trial Clinical Trials Arena14:28 17-Apr-25

Cullinan Therapeutics Receives Approval from European Medicines Agency to Initiate Phase 1 Trial of Cln-978, a… GlobeNewswire (Press Release)12:07 16-Apr-25

In the last month

EMA Seeks Input on a “Tailored Clinical Approach” in Biosimilar Development JD Supra20:53 8-Apr-25

Accord Receives Positive EMA Opinion for Two Denosumab Biosimilars JD Supra17:29 8-Apr-25

Avidity Biosciences Receives Orphan Drug Designation in Japan for Delpacibart Etedesiran… PR Newswire (Press Release)14:01 8-Apr-25

Comanche Biopharma Announces European Medicines Agency (EMA) Has Granted Orphan Drug Designation for CBP-4888 in… GlobeNewswire (Press Release)12:10 8-Apr-25

Veterinary Medicine Safety Day 2025 – Report Adverse Events to Improve the Safety of Veterinary Medicinal Products Paul-Ehrlich-Institut (Press Release)09:33 8-Apr-25

BeiGene (NasdaqGS:ONC) Gains 32% In A Quarter Amid Positive EMA Opinion On TEVIMBRA Simply Wall St01:01 6-Apr-25

Europe’s controversial quest for an Alzheimer’s drug EurActiv.com05:08 4-Apr-25

Sarepta/Roche Suspend Elevidys Gene Therapy Trials In Europe After Patient Death Benzinga20:41 3-Apr-25

EMA proposes streamlined approach for biosimilar development European Pharmaceutical Review15:43 2-Apr-25

Organon/Henlius announce EMA validation for Perjeta biosimilar HLX11 PMLiVE12:26 2-Apr-25

Averoa Receives Positive Opinion from the European Medicines Agency for Xoanacyl®, an Oral Therapy for Chronic Kidney… GlobeNewswire (Press Release)10:01 2-Apr-25

Helsinn Group submits a new formulation of Akynzeo® to the European Medicines Agency (EMA) GlobeNewswire (Press Release)10:01 2-Apr-25

Sydnexis Announces Positive CHMP Opinion in Europe for SYD-101 for Slowing the Progression of… Business Wire (Press Release)14:04 1-Apr-25

Eli Lilly’s Alzheimer’s drug not recommended by top European regulator WFYI Indianapolis21:29 31-Mar-25

Use Caution Regarding Commercial Treatment Offers of Unauthorised / Unapproved Advanced Therapy Medicinal Products Paul-Ehrlich-Institut (Press Release)14:33 31-Mar-25

Curis Provides Fourth Quarter 2024 Business Update PR Newswire (Press Release)13:06 31-Mar-25

OS Therapies Provides Regulatory Update on Rare Pediatric Cancer Immunotherapy Candidate… Business Wire (Press Release)12:44 31-Mar-25

EMA Recommends Five New Medicines for Approval PharmTech.com20:58 28-Mar-25

EU drugs regulator rejects Lilly’s Alzheimer’s drug Politico EU13:41 28-Mar-25

EU regulators block new Alzheimer’s drug over side effects euronews13:17 28-Mar-25

European Medicines Agency (EMA) Validates Henlius and Organon Filing for Perjeta® (pertuzumab)… Business Wire (Press Release)10:00 28-Mar-25

EC approves MSD’s pneumococcal 21-valent conjugate Capvaxive Pharmaceutical Technology09:45 27-Mar-25

FDA Approves Novartis Oral Treatment for Adults with C3 Glomerulopathy PharmTech.com19:02 25-Mar-25

FDA Grants Priority Review for Biologics License Application (BLA) and EMA Accepts Marketing… Business Wire (Press Release)11:32 25-Mar-25

EMA to review GSK’s Nucala for COPD treatment expansion Pharmaceutical Technology10:40 25-Mar-25

EMA and HMA Publish Joint Network Strategy to 2028 PharmTech.com20:50 24-Mar-25

EMA to Review Application for Expanded Indication for Sugemalimab in Unresectable NSCLC OncLive16:26 24-Mar-25

EMA accepts GSK's application to expand Nucala use London South East08:52 24-Mar-25

GSK has application to expand use of mepolizumab accepted by EMA London South East08:32 24-Mar-25

Plus500 buys Mehta Equities, EMA accepts GSK's application to extend use of Nucala ShareCast07:44 24-Mar-25

GSK’s application to expand use of Nucala (mepolizumab) for the treatment of COPD accepted for review by the European… GlaxoSmithKline (Press Release)07:10 24-Mar-25

CStone Pharmaceuticals Seeks EMA Approval for Sugemalimab in Stage III NSCLC TipRanks00:08 24-Mar-25

European Medicines Agency gives first green light to AI use citing liver biopsy trial NL Times15:12 21-Mar-25

New data on Mpox vaccine effectiveness ScienceDaily22:02 20-Mar-25

PathAI Announces EMA Qualification for aim-mash AI Assist, a Groundbreaking AI Tool for mash Clinical Trials GlobeNewswire (Press Release)16:01 20-Mar-25

Beware of unproven cancer treatments, EU medicine regulators say euronews14:45 20-Mar-25

EU health regulator clears use of AI tool in fatty liver disease trials Yahoo! UK & Ireland12:27 20-Mar-25

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18 Apr 08:48

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Latest news on the European Medicines Agency, also known as the EMA, a European Union agency responsible for the evaluation and supervision of pharmaceuticals.

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