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358,553 Results for "european medicines agency ema".
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Helsinn Group submits a new formulation of AKYNZEO® to the European Medicines Agency (EMA)
April 2, 2025
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2 min read
Press Releases
Dyne Therapeutics Receives European Medicines Agency (EMA) Orphan Drug Designation for DYNE-251 in Duchenne Muscular Dystrophy
April 24, 2025
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8 min read
Press Releases
Purespring Therapeutics granted European Medicines Agency (EMA) orphan drug designation for PS-002 for the treatment of patients with primary IgA nephropathy (IgAN)
April 28, 2025
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4 min read
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European Medicines Agency (EMA) Validates Henlius and Organon Filing for Perjeta® (pertuzumab) Biosimilar Candidate HLX11
March 31, 2025
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Comanche Biopharma Announces European Medicines Agency (EMA) Has Granted Orphan Drug Designation for CBP-4888 in sFlt1-mediated Preterm Preeclampsia
April 8, 2025
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Crinetics Pharmaceuticals Announces European Medicines Agency (EMA) Validation of Marketing Authorization Application (MAA) and Orphan Drug Designation (ODD) for Paltusotine in Acromegaly
March 28, 2025
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7 min read
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Valneva Provides Update Following European Medicines Agency Announcement on Use of IXCHIQ® in Elderly
May 8, 2025
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Moleculin Receives European Medicines Agency Approval to Expand Phase 3 MIRACLE Clinical Trial
May 12, 2025
·
8 min read
Genetown
Apellis Announces Pegcetacoplan MAA Review Has Been Reset to Day 180 of Initial Assessment by European Medicines Agency (EMA)
Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the European Medicines Agency (EMA) has reset the review of the marketing authorization application (MAA) for intravitreal pegcetacoplan for geographic atrophy to the last phase of the initial assessment (day 180).
April 26, 2024
·
2 min read
Edgewise Receives European Medicines Agency (EMA) Orphan Drug Designations for Sevasemten (EDG-5506) for the Treatment of Becker and Duchenne Muscular Dystrophies
Edgewise Therapeutics, Inc. today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designations for sevasemten for the treatment of Becker muscular dystrophy (Becker) and for the treatment of Duchenne muscular dystrophy (Duchenne).
April 23, 2024
·
5 min read
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