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

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...

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...

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...

FDA Approves Gomekli (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN

drugs.com - 11/Feb 22:02

STAMFORD, Conn., Feb. 11, 2025 -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare...

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

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...

FDA Approves Vimseltinib to Treat Tenosynovial Giant Cell Tumor

medindia.net - 20/Feb 21:17

Vimseltinib, a new drug has been approved by the U.S. Food and Drug Administration (FDA) to treat adults with a rare rare condition called...

FDA Approves Genentech’s Evrysdi Tablet as First and Only Tablet for Spinal Muscular Atrophy (SMA)

drugs.com - 12/Feb 00:02

South San Francisco, CA -- February 12, 2025 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S....

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...

FDA Approves Vimkunya (chikungunya vaccine, recombinant) for Prevention of Disease Caused by Chikungunya Virus

drugs.com - 14/Feb 21:02

COPENHAGEN, Denmark, February 14, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today that the U.S. Food and Drug Administration (FDA) has...

U.S. FDA Approves Expanded Label for Astellas' Izervay (avacincaptad pegol intravitreal solution) for Geographic Atrophy

drugs.com - 12/Feb 01:02

TOKYO, Feb. 12, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the U.S. Food and...

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