Showing posts with label Treatment. Show all posts
Showing posts with label Treatment. Show all posts
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...
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...
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...
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...
Friday, November 7, 2025

FDA Approves Gomekli (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN

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SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, anno...
Monday, November 3, 2025

FDA Approves Journavx (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain

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Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)   announced   U.S. Food and Drug Administration (FDA)   approval of  Journavx (suzetrigin...
Wednesday, October 29, 2025

FDA Approves Palsonify (paltusotine) for the Treatment of Acromegaly in Adults

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Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that the U.S. Food and Drug Administration (FDA) approved Palsonify (paltusot...
Tuesday, August 12, 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 has announced   the FDA approval of  Harliku (nitisinone) Tablets for the ...
Thursday, August 7, 2025

FDA Approves Ekterly (sebetralstat) the First and Only Oral On-demand Treatment for Hereditary Angioedema (HAE)

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KalVista Pharmaceuticals, Inc.  announced  the U.S. Food and Drug Administration (FDA) approval of Ekterly (sebetralstat), a novel plasma ka...