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Press Releases

European Commission (EC) Extends the Approval of Evkeeza® (evinacumab) to Children as Young as 6-months Old with Homozygous Familial Hypercholesterolemia (HoFH)

January 6, 2025

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10 min read

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

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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

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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

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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

Press Releases

European Commission Approves the Extension of the Indication of Palforzia® to the Treatment of Toddlers With Confirmed Peanut Allergy

January 9, 2025

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5 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