Saturday, January 31, 2026

FDA Approves Kygevvi (doxecitine and doxribtimine) for the Treatment of Thymidine Kinase 2 Deficiency

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UCB (Euronext Brussels: UCB), a global biopharmaceutical company, today announced that Kygevvi has been granted approval by the U.S. Food an...
Friday, January 30, 2026

FDA Approves Epioxa (riboflavin 5’-phosphate) Ophthalmic Solution for the Treatment of Keratoconus

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Glaukos Corporation, an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, c...
Thursday, January 29, 2026

FDA Approves Contepo (fosfomycin) for Injection for the Treatment of Complicated Urinary Tract Infections

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In Continuation of my update on fosfomycin The U.S. Food and Drug Administration (FDA) has approved Contepo (fosfomycin) for injection for t...
Wednesday, January 28, 2026

FDA Approves Contepo (fosfomycin) for Injection for the Treatment of Complicated Urinary Tract Infections

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The U.S. Food and Drug Administration (FDA) has approved Contepo (fosfomycin) for injection for the treatment of patients 18 years of age an...
Tuesday, January 27, 2026

FDA Approves Javadin (clonidine hydrochloride) Oral Solution for the Treatment of Hypertension

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In continuation of my update on Clonidine Azurity Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approval of  J...
Monday, January 26, 2026

FDA Approves Lynkuet (elinzanetant) for Moderate to Severe Hot Flashes Due to Menopause

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Bayer announced  the U.S. Food and Drug Administration (FDA) approval of  Lynkuet® (elinzanetant) 60mg capsules, the first and only dual neu...
Saturday, January 10, 2026

FDA Grants Accelerated Approval to Forzinity (elamipretide hydrochloride) for the Treatment of Barth Syndrome

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In continuation of mu update on elamipretide Stealth BioTherapeutics Inc. (the “Company” or “Stealth”),  announced  the U.S. Food and Drug A...
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...