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Drugs.com - New Drug Approvals

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Last updated about 22 hours ago

Repatha Now Indicated for Adults at Increased Risk for Major Adverse Cardiovascular Events Due to Uncontrolled LDL-C

4 days ago

THOUSAND OAKS, Calif., Aug. 25, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced...

FDA Approves Dawnzera (donidalorsen) as the First and Only RNA-targeted Prophylactic Treatment for Hereditary Angioedema

8 days ago

CARLSBAD, Calif.--(BUSINESS WIRE)--Aug. 21, 2025-- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today...

FDA Approves Tonmya (cyclobenzaprine hydrochloride sublingual tablets) for the Treatment of Fibromyalgia

13 days ago

CHATHAM, N.J., Aug. 15, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp...

FDA Approves Papzimeos (zopapogene imadenovec-drba) for the Treatment of Adults with Recurrent Respiratory Papillomatosis

13 days ago

GERMANTOWN, Md, Aug. 15, 2025 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a...

Wegovy Granted Accelerated Approval in the US for the Treatment of MASH

13 days ago

Bagsværd, Denmark, 15 August 2025 – Novo Nordisk today announced that the...

FDA Approves Brinsupri (brensocatib) for the Treatment of Non-Cystic Fibrosis Bronchiectasis

16 days ago

BRIDGEWATER, N.J., Aug. 12, 2025 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a...

FDA Approves KETARx (ketamine) for Surgical Pain Management

17 days ago

TORONTO, ON – August 11, 2025 – PharmaTher Holdings Ltd. (the “Company”...

FDA Grants Accelerated Approval to Hernexeos (zongertinib) for Previously Treated Patients with HER2-Mutant Advanced NSCLC

20 days ago

Ridgefield, Conn., U.S. and Ingelheim, Germany , August 8, 2025 -- Boehringer...

FDA Grants Accelerated Approval to Modeyso (dordaviprone) for the Treatment of Recurrent H3 K27M-Mutant Diffuse Midline Glioma

23 days ago

DUBLIN, Aug. 6, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today...

FDA Approves Expanded Indication for Avtozma (tocilizumab-anoh) Intravenous (IV) Formulation in Cytokine Release Syndrome (CRS)

23 days ago

INCHEON, South Korea, Aug. 6, 2025 -- Celltrion, Inc. today announced that...