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354,445 Results for "european medicines agency ema".
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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
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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
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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
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5 min read
Press Releases
European Medicines Agency Validates Gilead’s Marketing Authorization Application and EU-Medicines for All Application for Twice-Yearly Lenacapavir for HIV Prevention
February 25, 2025
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7 min read
Pharm Country
European Medicines Agency (EMA) Validates Henlius and Organon Filings for Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14
Shanghai Henlius Biotech, Inc. and Organon announced that the European Medicines Agency has validated the marketing authorization applications for HLX14, an investigational Prolia® and Xgeva® biosimilar.
May 24, 2024
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7 min read
GLP-1
EMA to Investigate Eye Risk for Novo’s Ozempic: Reuters
Following an appeal by the Danish Medicines Agency, the European Union’s drug regulator will review two new studies that have strengthened the link between Novo Nordisk’s blockbuster GLP-1 and a rare eye disease.
December 18, 2024
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2 min read
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Annalee Armstrong
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
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7 min read
Job Trends
European Medicines Agency Validates Bristol Myers Squibb’s Application for Subcutaneous Nivolumab
Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated the extension application to introduce a new route of administration (subcutaneous use) for Opdivo®.
June 21, 2024
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45 min read
Press Releases
Ocugen Announces Positive Opinion of European Medicines Agency’s Committee for Advanced Therapies for Advanced Therapy Medicinal Product Classification for Modifier Gene Therapy Candidate OCU400 for Retinitis Pigmentosa
February 3, 2025
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5 min read
Press Releases
C3i Center, a Canadian company, receives approval from the EMA to manufacture cell therapy products for the European market
February 19, 2025
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2 min read
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