Drugs.com - New Drug Approvals
New drug approvals news from Drugs.com. Comprehensive, up-to-date drug news for consumers and healthcare professionals.
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FDA Approves Pimjetmi (pimicotinib) for Patients with Tenosynovial Giant Cell Tumor
November 10, 2026 -- EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the US and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved Pimjetmi (pimicotinib), a once-daily oral colony... -
FDA Approves Sunharbo (asundexian) in Combination with Antiplatelet Therapy for Secondary Stroke Prevention
WHIPPANY, N.J.-- November 9, 2026 -- Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Sunharbo (asundexian), 50 mg tablets, a first-in-class, once daily, Factor XIa inhibitor indicated in combination with... -
Johnson & Johnson Announces U.S. FDA Approval of Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) as First and Only Dual-Targeted Therapy for Advanced Head and Neck Cancer
New Brunswick, N.J. (November 5, 2026) – Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) (subcutaneous... -
FDA Grants Accelerated Approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for Recurrent Respiratory Papillomatosis
PLYMOUTH MEETING, Pa., Oct. 30, 2026 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases... -
Ilumya (tildrakizumab-asmn) Approved in the U.S. for the Treatment of Adults with Active Psoriatic Arthritis
MUMBAI, India and PRINCETON, N.J., Oct. 30, 2026 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries and/or associated companies)... -
FDA Approves Lucamzi (ranibizumab-blrz), a Biosimilar to Lucentis
Solna, Sweden 27 October 2026 – Lucamzi™ (ranibizumab-blrz) biosimilar to Lucentis® has been approved by FDA in the US. Xbrane will finalize preparation for an upcoming launch of the product during 2027 together with its... -
Pfizer’s Talzenna Plus Xtandi FDA-Approved for an Earlier Metastatic Prostate Cancer Treatment Setting
NEW YORK--(BUSINESS WIRE) October 26, 2026 -- Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has expanded approval of Talzenna (talazoparib) in combination with Xtandi (enzalutamide) to the treatment of... -
Novo’s Awiqli Receives FDA Approval as the First and Only Once-Weekly Insulin for Children 10 Years of Age and Older with Type 2 Diabetes
PLAINSBORO, N.J., Oct. 23, 2026 /PRNewswire/ -- Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Awiqli (insulin icodec-abae) injection 700 units/mL, the first once-weekly, long-acting basal insulin, as an...