Showing posts with label FDA approval. Show all posts
Showing posts with label FDA approval. Show all posts
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...
Friday, October 31, 2025

FDA Approves Subvenite (lamotrigine) Oral Suspension for Epilepsy and Bipolar Disorder

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OWP Pharmaceuticals announced the U.S. Food and Drug Administration (FDA)  approval of  Subvenite Oral Suspension, the first and only lamotr...
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...
Saturday, October 25, 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...
Friday, October 24, 2025

FDA Approves Bondlido (lidocaine topical system) for the Treatment of Post-Herpetic Neuralgia

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MEDRx announced  the U.S. Food and Drug Administration (FDA)  approval of  Bondlido, a lidocaine patch MEDRx Group and D. Western Therapeuti...
Thursday, October 23, 2025

FDA Approves Zusduri (mitomycin) for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

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UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial ...
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...
Friday, August 1, 2025

FDA Approves Anzupgo (delgocitinib) Cream for the Treatment of Chronic Hand Eczema

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LEO Pharma, a global leader in medical dermatology, announced   the U.S. Food and Drug Administration (FDA) approval of  Anzupgo ®  (delgoci...
Monday, June 30, 2025

FDA Approves Symbravo (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in Adults

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Axsome Therapeutics, Inc.  announced that the U.S. Food and Drug Administration (FDA) has approval of   Symbravo   (meloxicam and rizatripta...
Friday, June 27, 2025

FDA Approves Grafapex (treosulfan) Preparative Regimen for Allogeneic Hematopoietic Stem Cell Transplantation

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Medexus was informed that the FDA approved Grafapex, an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoi...
Wednesday, June 25, 2025

FDA Approves Arbli (losartan potassium) Oral Suspension as the First Ready-to-Use Oral Liquid Losartan in the U.S.

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In continuation of my update on losartan Scienture Holdings, Inc.   announced the U.S. Food and Drug Administration (FDA)  approval of SCN-1...
Monday, June 23, 2025

FDA Approves HemiClor (chlorthalidone) for the Treatment of Hypertension

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PRM Pharma, LLC  announced the U.S. Food and Drug Administration (FDA) approval of HemiClor (12.5 mg chlorthalidone) tablets for the treatme...
Friday, June 20, 2025

FDA Approves Blujepa (gepotidacin) for the Treatment of Uncomplicated Urinary Tract Infections

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GSK plc  announced the US Food and Drug Administration (FDA) approval of Blujepa (gepotidacin) for the treatment of female adults (≥40 kg) a...