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356,981 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
European Medicines Agency (EMA) Validates Henlius and Organon Filing for Perjeta® (pertuzumab) Biosimilar Candidate HLX11
March 31, 2025
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6 min read
Press Releases
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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Press Releases
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
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
Lone Star Bio
European Medicines Agency (EMA) Grants Orphan Drug Designation for Moleculin’s Treatment of Acute Myeloid Leukemia (AML)
Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation to Annamycin for the treatment of AML.
April 18, 2024
·
5 min read
Press Releases
Akebia Therapeutics Announces Positive Opinion of European Medicines Agency for XOANACYL®, an Oral Therapy for Chronic Kidney Disease Licensed to Averoa
April 4, 2025
·
3 min read
Press Releases
AVEROA Receives Positive Opinion from the European Medicines Agency for XOANACYL®, an Oral Therapy for Chronic Kidney Disease (CKD)
April 2, 2025
·
4 min read
Biotech Bay
Ultragenyx Receives PRIME Designation from European Medicines Agency (EMA) for GTX-102 for the Treatment of Angelman Syndrome
Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the European Medicines Agency (EMA) has granted Priority Medicine (PRIME) designation to GTX-102 for the treatment of Angelman syndrome (AS).
February 5, 2024
·
7 min read
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