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Maroc Maroc - DRUGS.COM - New Drug Approvals - 16/Feb 22:02

FDA Approves Ospomyv (denosumab-dssb), a Biosimilar to Prolia

INCHEON, Korea – Feb 16, 2025 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Ospomyv (denosumab-dssb; SB16; 60 mg pre-filled syringe)...

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FDA Approves Xbryk (denosumab-dssb), a Biosimilar to Xgeva

drugs.com - 16/Feb 22:02

INCHEON, Korea – Feb 16, 2025 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved...

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Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma

drugs.com - 11/Feb 18:02

TARRYTOWN, N.Y., Feb. 11, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug...

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U.S. FDA Approves Pfizer’s Adcetris Combination Regimen for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

drugs.com - 12/Feb 00:02

NEW YORK--(BUSINESS WIRE) February 12, 2025 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved...

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LIB Therapeutics Announces FDA Acceptance of Biologics License Application for Lerodalcibep to Lower LDL-Cholesterol Across Broad Patient Population

drugs.com - 10/Feb 19:02

CINCINNATI- February 10, 2025 --LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company today announced the U.S. Food and...

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FDA Approves First Rapid-Acting Insulin Biosimilar for Patients With Diabetes

drugs.com - 19/Feb 22:06

WEDNESDAY, Feb. 19, 2025 -- The U.S. Food and Drug Administration has approved Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin...

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FDA Approves Merilog, First Rapid-Acting Insulin Biosimilar for Patients With Diabetes

drugs.com - 19/Feb 22:02

WEDNESDAY, Feb. 19, 2025 -- The U.S. Food and Drug Administration has approved Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin...

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FDA Approves Romvimza (vimseltinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumor

drugs.com - 14/Feb 20:02

Osaka, Japan and Waltham, Massachusetts, February 14, 2025 – Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino;...

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FDA Approves Merilog (insulin-aspart-szjj), a Biosimilar to NovoLog

drugs.com - 16/Feb 22:02

February 14, 2025 -- Today, the U.S. Food and Drug Administration approved Merilog (insulin-aspart-szjj) as biosimilar to NovoLog (insulin aspart) for...

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FDA Approves Tablet Form of Evrysdi for Spinal Muscular Atrophy

drugs.com - 18/Feb 15:28

TUESDAY, Feb. 18, 2025 -- The U.S. Food and Drug Administration has approved a new drug application for a tablet version of Evrysdi (risdiplam) for...

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Biohaven Announces FDA Acceptance and Priority Review of Troriluzole New Drug Application for the Treatment of Spinocerebellar Ataxia

drugs.com - 11/Feb 22:02

NEW HAVEN, Conn., Feb. 11, 2025 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), today announced that the US Food and Drug...

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