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Tuesday

Regeneron's Applications for gMG Drug Accepted by FDA and EMA Zacks 20:32 Tue, 23 Jun

FDA, EMA to Review Cemdisiran Regulatory Submissions in AChR-Positive Myasthenia Gravis Rare Disease Advisor 17:10 Tue, 23 Jun

Yuhan secures EMA orphan drug designation for Gaucher disease candidate Korea Biomedical Review 02:31 Tue, 23 Jun

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Monday

Regeneron’s New Drug Application for cemdisiran accepted for review by FDA and EMA PMLiVE 12:32 Mon, 22 Jun

Cemdisiran Regulatory Submissions Accepted for Review by FDA and EMA for the Treatment of Generalized Myasthenia Gravis (gMG) Regeneron Pharmaceuticals (Press Release) 12:01 Mon, 22 Jun

KRPIA welcomes Korean regulator's 1st international joint drug review, expects broader regulatory harmonization Korea Biomedical Review 09:11 Mon, 22 Jun

In the last month

WuXi Biologics' Suzhou Biosafety Testing Center Received Fourth EMA GMP Certification, Enabling 19 Commercial Products ... American Pharmaceutical Outsourcing (Press Release) 14:05 Thu, 18 Jun

WuXi Biologics' Suzhou Biosafety Testing Center Received Fourth EMA GMP Certification, Enabling 19 Commercial Products for the European Market PR Newswire (Press Release) 05:58 Thu, 18 Jun

Zai Lab’s zocilurtatug pelitecan secures EMA orphan drug status Pharmaceutical Technology 09:57 Wed, 17 Jun

Korea joins Europe in landmark joint review of biopharmaceuticals The Korea Times 04:11 Wed, 17 Jun

Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas Business Wire (Press Release) 12:02 Tue, 16 Jun

EMA Begins Review of Bayer's Asundexian Filing for Stroke Prevention Zacks 16:22 Thu, 11 Jun

EMA validates Bayer’s asundexian application for ischaemic stroke Pharmaceutical Technology 09:59 Thu, 11 Jun

Dutch patients waiting 21 months for new cancer treatments DutchNews.nl 14:27 Wed, 10 Jun

European Medicines Agency confirms asundexian marketing authorization application for assessment in secondary prevention of ischemic stroke Bayer (Press Release) 07:39 Wed, 10 Jun

The European Medicines Agency (EMA)'s failure to reply to a request for feedback from an unsuccessful candidate in a staff selection procedure The European Ombudsman (Press Release) 07:22 Tue, 09 Jun

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IntraBio Announces Submission of Variation Application to the European Medicines Agency for Aqneursa® for Ataxia-Telangiectasia Business Wire (Press Release) 16:14 Fri, 05 Jun

EMA and AMA collaborate on Ebola trials amid public health emergency Clinical Trials Arena 14:52 Thu, 04 Jun

Podcast: Assessing the EMA’s new innovative medical device pathway pilot Verdict Medical Devices 11:36 Tue, 02 Jun

EMA recommends next season's Covid vaccines should target Xfg variant Rock Hill Herald 14:52 Fri, 29 May

The 2026 MedTech Forum: innovation and regulation lead the agenda Verdict Medical Devices 13:17 Fri, 29 May

Hansa Biopharma’s Idefrix leads to one-year GvHD survival in kidney transplant Clinical Trials Arena 20:32 Thu, 28 May

Nestlé and IdB Holding S.p.A. Enter Into Licensing Agreement for Vowst® in Europe PR Newswire (Press Release) 14:09 Thu, 28 May

Ribo Announces Phase 2 Clinical Trial Submission to EMA, Further Advancing siRNA Therapeutics in Thromboembolic Disease PR Newswire (Press Release) 03:57 Thu, 28 May

Hansa Biopharma reports positive efficacy and safety results from Idefirix® European post authorization study in kidney transplantation PR Newswire (Press Release) 07:30 Wed, 27 May

EMA recommends eight new medicines for approval EU Reporter 18:23 Tue, 26 May

EMA recommends approvals for both oral and high-dose pen of Wegovy Pharmaceutical Technology 17:03 Tue, 26 May

Sacituzumab govitecan receives positive CHMP opinion in first-line metastatic triple-negative Breast cancer ecancer 11:39 Tue, 26 May

A Look At MedinCell (ENXTPA:MEDCL) Valuation After EMA Accepts TEV-749 Marketing Authorization Application Simply Wall St 21:26 Mon, 25 May

CHMP Backs EU Approval of Novo Nordisk's Wegovy Pill for Obesity Zacks 17:02 Mon, 25 May

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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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