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European Biosimilar Regulatory Update | Goodwin

In the past few weeks, the European Commission provided marketing authorization for biosimilars of denosumab and omalizumab, as well as an ophthalmic formulation of bevacizumab. ....

United States , European Commission , Committee For Medicinal Products Human Use , European Union , European Medicines Agency , Outlook Therapeutics , Bio Thera Solution , Medicinal Products , Human Use ,

Akantior therapy for amoeba keratitis

Akantior therapy for amoeba keratitis
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European Medicines Agency , Drug Administration , Committee For Medicinal Products Human Use , Dear Editor , Medicinal Products , Human Use , Acanthamoeba Keratitis , Sight Threatening Eye ,

AbbVie Skyrizi Gets CHMP Nod for Ulcerative Colitis in EU

AbbVie Skyrizi Gets CHMP Nod for Ulcerative Colitis in EU
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AbbVie Skyrizi Gets CHMP Nod for Ulcerative Colitis in EU - AbbVie (NYSE:ABBV), ALX Oncology Holdings (NASDAQ:ALXO)

AbbVie (NYSE: ABBV) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending approval of Skyrizi (risankizumab) in the EU to treat adults with moderately to severely active ulcerative colitis (UC). ....

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CStone Announces European Medicine Agency CHMP Recommends Approval of Cejemly® (sugemalimab, anti-PD-L1) as First-Line Treatment for NSCLC

SUZHOU, China, June 2, 2024 /PRNewswire/ — CStone Pharmaceuticals (HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and… ....

United Kingdom , Jason Yang , European Medicines Agency , Regulatory Agency , Committee For Medicinal Products Human Use , Cstone Pharmaceuticals , European Commission , Drug Administration , National Medical Products Administration , Central Eastern Europe , Medicinal Products , Human Use , Executive Director , Lancet Oncology , Nature Cancer , Combined Positive Score , Transl Lung Cancer Res ,