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Press Releases

Samsung Bioepis Gains European Commission (EC) Approval for Denosumab Biosimilar (OBODENCE™, XBRYK™)

February 17, 2025

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4 min read

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

Europe

Biogen, Eisai Continue Leqembi’s European Rally as CHMP Reaffirms Positive Opinion

Leqembi’s application now moves forward to the European Commission, which will issue a formal verdict for the injection that will apply to all EU member states as well as Norway, Liechtenstein and Iceland.

March 3, 2025

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2 min read

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Tristan Manalac

Press Releases

Celltrion Expands Biosimilar Portfolio in the European Union Following European Commission Approval of Two Biosimilars

February 18, 2025

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8 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

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

Press Releases

WELIREG® (belzutifan) Receives First European Commission Approval for Two Indications

February 18, 2025

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17 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