FDA Approves Stoboclo (denosumab-bmwo), a Biosimilar to Prolia

FDA Approves Osenvelt (denosumab-bmwo), a Biosimilar to Xgeva

drugs.com - 03/Mar 00:03

JERSEY CITY, N.J., March 3, 2025 /PRNewswire/ -- Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved Osenvelt...

FDA Approves Omlyclo (omalizumab-igec), an Interchangeable Biosimilar to Xolair

drugs.com - 07/Mar 22:03

March 07, 2025 -- Today, the U.S. Food and Drug Administration approved as the first interchangeable biosimilar to Xolair (omalizumab). Omlyclo, like...

FDA Approves TNKase (tenecteplase) for the Treatment of Acute Ischemic Stroke in Adults

drugs.com - 03/Mar 22:03

South San Francisco, CA -- March 3, 2025 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food...

FDA Approves Encelto (revakinagene taroretcel-lwey) for the Treatment of Macular Telangiectasia Type 2 (MacTel)

drugs.com - 06/Mar 22:03

CUMBERLAND, R.I.--(BUSINESS WIRE)--Neurotech Pharmaceuticals, Inc., a private biotech company focused on developing transformative therapies for...

FDA Approves Odactra for the Treatment of House Dust Mite Allergy in Young Children

drugs.com - 28/Feb 23:02

February 27, 2025 -- ALK (ALKB:DC / OMX: ALK B) today announced that the US Food and Drug Administration (FDA) has approved ALK’s Odactra tablet...

FDA Approves Miudella (copper intrauterine system) for the Prevention of Pregnancy

drugs.com - 24/Feb 22:02

ROSWELL, GA, February 24, 2025 – Sebela Women’s Health Inc., a part of Sebela Pharmaceuticals, today announced that the U.S. Food and Drug...

FDA Approves TNKase for Acute Ischemic Stroke

drugs.com - 06/Mar 21:06

THURSDAY, March 6, 2025 -- The U.S. Food and Drug Administration has approved TNKase (tenecteplase), a thrombolytic or clot-dissolving agent, for the...

Indivior Announces FDA Approval of Label Changes for Sublocade (buprenorphine extended-release) Injection

drugs.com - 24/Feb 23:02

Richmond, VA, February 24, 2025 – Indivior PLC (Nasdaq/LSE: INDV), a global leader in addiction treatment, today announced that the U.S. Food...

Depemokimab Applications Accepted for Review by the US FDA for Asthma with Type 2 Inflammation and for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

drugs.com - 03/Mar 21:03

London, UK -- 03 March 2025 -- GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has accepted for review the Biologics...

Tevimbra Approved in U.S. for First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma in Combination with Chemotherapy

drugs.com - 04/Mar 02:03

SAN MATEO, Calif.--(BUSINESS WIRE) Mar 04, 2025 -- BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that intends to...

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