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371,404 Results for "european medicines agency ema".
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Press Releases
Longeveron Granted Small or Medium-sized Enterprise (SME) Status by the European Medicines Agency (EMA)
June 9, 2026
·
7 min read
Press Releases
European Medicines Agency Expedites Assessment of Revolution Medicines’ Daraxonrasib Under Phased Review Process
July 7, 2026
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7 min read
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Savara Announces European Medicines Agency (EMA) Validation of Marketing Authorization Application (MAA) for MOLBREEVI* in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
March 30, 2026
·
5 min read
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IntraBio Announces Submission of Variation Application to the European Medicines Agency for AQNEURSA® for Ataxia-Telangiectasia
June 7, 2026
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4 min read
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Ray Therapeutics Granted Priority Medicines (PRIME) Designation from the European Medicines Agency for RTx-015 in Retinitis Pigmentosa
April 29, 2026
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3 min read
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Niagen Bioscience Receives Exclusive U.S. FDA Rare Pediatric Disease (RPD) Designation and European Medicines Agency Orphan Medicinal Product Designation (OMPD) for NB4168 for the Treatment of Ataxia Telangiectasia (A-T)
July 13, 2026
·
10 min read
Press Releases
WuXi Biologics’ Suzhou Biosafety Testing Center Received Fourth EMA GMP Certification, Enabling 19 Commercial Products for the European Market
June 18, 2026
·
4 min read
Press Releases
The European Medicines Agency Accepts Teva’s Marketing Authorization Application for Olanzapine Long-Acting Injectable (TEV-‘749) for the Treatment of Schizophrenia in Adults
May 21, 2026
·
7 min read
Press Releases
IntraBio Receives Positive European Medicines Agency Opinion for Orphan Medicinal Product Designation for Acetylleucine for CACNA1A Disorders
February 25, 2026
·
2 min read
Press Releases
The African Medicines Agency (AMA) and U.S. Pharmacopeia (USP) Sign Memorandum of Understanding to Advance Access to Safe, Effective & Quality-Assured Medicines Across Africa
The agreement establishes a framework for cooperation between the African Medicines Agency (AMA) and the U.S. Pharmacopeia to strengthen regulatory systems, enhance capacity building, and improve access to quality-assured medical products across Africa.
April 29, 2026
·
3 min read
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