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299,189 Results for "european commission ec".
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Press Releases
Samsung Bioepis and Biogen Receive European Commission (EC) Approval for Aflibercept Biosimilar, OPUVIZ™
November 18, 2024
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8 min read
Job Trends
HUTCHMED Announces European Commission Approval for FRUZAQLA® (fruquintinib) Received by Takeda
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that its partner Takeda (TSE:4502/NYSE:TAK) has received notification from the European Commission (“EC”) that it has approved FRUZAQLA®.
June 21, 2024
·
17 min read
Biotech Beach
Arcturus Therapeutics Receives Orphan Medicinal Product Designation from the European Commission (EC), for ARCT-032, for the Treatment of Cystic Fibrosis
Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT) today announced that the European Commission (EC), based on a positive opinion issued by the European Medicines Agency (EMA), has granted orphan medicinal product designation for the Company’s product candidate ARCT-032 to treat Cystic Fibrosis (CF).
February 22, 2024
·
5 min read
Genetown
Biogen Receives European Commission Approval for QALSODY® (tofersen), the First Therapy to Treat a Rare, Genetic Form of ALS
Biogen Inc announced the European Commission (EC) has granted marketing authorization under exceptional circumstances and maintained orphan designation for QALSODY.
May 30, 2024
·
10 min read
Pharm Country
PTC Therapeutics Announces European Commission Returns Translarna™ Opinion to CHMP For Re-evaluation
PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the European Commission (EC) has decided not to adopt the CHMP’s negative opinion of January 24, 2024 on the annual renewal of the conditional marketing authorization of Translarna™ (ataluren) and has returned the opinion to the CHMP for re-evaluation.
May 20, 2024
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6 min read
Pharm Country
Rocket Pharmaceuticals Receives Orphan Medicinal Product Designation from the European Commission for RP-A601 for PKP2 Arrhythmogenic Cardiomyopathy
Rocket Pharmaceuticals, Inc. today announced that the European Commission (EC), based on a positive opinion issued by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA), has granted orphan medicinal product designation for RP-A601.
May 29, 2024
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7 min read
Pharm Country
European Commission Approves Pfizer’s EMBLAVEO® for Patients with Multidrug-Resistant Infections and Limited Treatment Options
Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for EMBLAVEO® (aztreonam-avibactam) for the treatment of adult patients with complicated intra-abdominal infections.
April 22, 2024
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10 min read
Press Releases
Teva Statement on European Commission Decision; Company to Appeal
November 1, 2024
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1 min read
Press Releases
Catalent and Novo Holdings Receive European Commission Unconditional Approval for Pending Transaction
December 9, 2024
·
5 min read
Pierre Fabre Laboratories announce granting of European marketing authorization for OBGEMSA™ (vibegron) in overactive bladder.
The European Commission (EC) has authorized the marketing of OBGEMSA™ (vibegron) by Pierre Fabre Laboratories for the symptomatic treatment of overactive bladder syndrome in adults, a particularly debilitating condition affecting over 70 million patients* in Europe.
June 28, 2024
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2 min read
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