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Drugs.com - New Drug Approvals

Get the latest updates from Drugs.com - New Drug Approvals directly as they happen.

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Last updated about 14 hours ago

FDA Approves Vybrique (sildenafil) Oral Film to Treat Men with Erectile Dysfunction

4 days ago

Parsippany, NJ, February 5, 2026 – IBSA USA, the U.S. subsidiary of...

Novo Nordisk Introduces Ozempic Pill; Available in the US Q2 2026

5 days ago

PLAINSBORO, N.J., February 4, 2026 – Novo Nordisk today announced that the...

FDA Approves Yuvezzi (carbachol and brimonidine tartrate) Ophthalmic Solution to Treat Presbyopia

12 days ago

LONDON, U.K. and SEATTLE, Wash., January 28, 2026 – Tenpoint Therapeutics, Ltd...

Darzalex Faspro-Based Quadruplet Regimen Approved for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible

13 days ago

HORSHAM, Pa., January 27, 2026 – Johnson & Johnson (NYSE:JNJ) announced today...

FDA Approves Filkri (filgrastim-laha), a Biosimilar to Neupogen

25 days ago

January 15, 2026 - The U.S. Food and Drug Administration has approved...

FDA Approves Zycubo (copper histidinate) for Children With Menkes Disease

27 days ago

Solana Beach, CA – JANUARY 13, 2026 – Sentynl Therapeutics Inc. (“Sentynl”)...

FDA Approves Zycubo (copper histidinate) for Children With Menkes Disease

28 days ago

January 12, 2026 -- The U.S. Food and Drug Administration today approved...

FDA Approves Nereus (tradipitant) for the Prevention of Motion Sickness

about 1 month ago

WASHINGTON, Dec. 30, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA)...

FDA Approves Yartemlea (narsoplimab-wuug) for the Treatment of Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy

about 2 months ago

SEATTLE--(BUSINESS WIRE)--Dec. 24, 2025-- Omeros Corporation (NASDAQ: OMER) today announced that the...

FDA Approves Aqvesme (mitapivat) for the Treatment of Anemia in Adults with Alpha- or Beta-Thalassemia

about 2 months ago

CAMBRIDGE, Mass., Dec. 23, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq...