Thursday, January 8, 2026

FDA Approves Wayrilz (rilzabrutinib) for Immune Thrombocytopenia

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The US Food and Drug Administration (FDA) has approved Wayrilz (rilzabrutinib) for adults with persistent or chronic immune thrombocytopenia...
Tuesday, January 6, 2026

FDA Approves Wayrilz (rilzabrutinib) for Immune Thrombocytopenia

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FDA Approves Wayrilz (rilzabrutinib) for Immune Thrombocytopenia
Monday, January 5, 2026

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

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Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced the U.S. Food and Drug Administration (FDA) approval of Dawnzera (donidalorsen) for pro...
Friday, January 2, 2026

FDA Approves Inlexzo (gemcitabine intravesical system) for the Treatment of Non-Muscle Invasive Bladder Cancer

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In continuation of my update on  gemcitabine  Johnson & Johnson (NYSE:JNJ) announced  the U.S. Food and Drug Administration (FDA) approv...
Thursday, January 1, 2026

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

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Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP),  announced the U.S. Food and Drug Administration (FDA) approval of  Tonmya™ (cyclobenzap...
Wednesday, December 24, 2025

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

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Insmed Incorporated (Nasdaq: INSM),  announced  the U.S. Food and Drug Administration (FDA)  approval of  first-in-class Brinsupri (brensoca...
Friday, December 19, 2025

FDA Approves KETARx (ketamine) for Surgical Pain Management

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PharmaTher Holdings Ltd. announced     the U.S. Food and Drug Administration (FDA) approval of  KETARx™, on August 8th, 2025, for its indica...
Tuesday, December 16, 2025

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

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Boehringer Ingelheim’s Hernexeos (zongertinib tablets) has been approved by the U.S. Food and Drug Administration (FDA). The kinase inhibito...
Monday, December 15, 2025

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

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Jazz Pharmaceuticals plc (Nasdaq: JAZZ)  announced the U.S. Food and Drug Administration (FDA) accelerated approval of  Modeyso (dordavipron...
Saturday, December 13, 2025

FDA Approves Vostally (ramipril) Oral Solution for the Treatment of Hypertension in Adults

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Rosemont Pharmaceuticals, Inc. announced  the U.S. Food and Drug Administration (FDA)  approval of  Vostally (ramipril) Oral Solution, an an...
Wednesday, December 10, 2025

FDA Approves Sephience (sepiapterin) for the Treatment of Children and Adults Living with Phenylketonuria

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PTC Therapeutics, Inc. (NASDAQ: PTCT) announced   U.S. Food and Drug Administration (FDA)  approval of Sephience™ (sepiapterin) for the trea...
Tuesday, December 9, 2025

FDA Approves Enbumyst (bumetanide) Nasal Spray for the Treatment of Edema Associated with Congestive Heart Failure, Liver Disease and Kidney Disease

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Corstasis Therapeutics Inc., announced the U.S. Food and Drug Administration (FDA)  approval of  Enbumyst (bumetanide nasal spray). Enbumyst...
Monday, December 8, 2025

FDA Approves Harliku (nitisinone) for the Treatment of Patients with Alkaptonuria

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In continuation of my update on Nitisinone Cycle Pharmaceuticals announced the FDA approval of  Harliku (nitisinone) Tablets for the reducti...