Showing posts with label FDA approval. Show all posts
Showing posts with label FDA approval. Show all posts
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...
Wednesday, June 18, 2025

FDA Approves Vykat XR (diazoxide choline) to Treat Hyperphagia in Prader-Willi Syndrome

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Soleno Therapeutics, Inc.  announced  the U.S. Food and Drug Administration (FDA)  approval of  Vykat XR (diazoxide choline) extended-releas...
Monday, September 23, 2024

FDA Approves Libervant (diazepam) Buccal Film for the Treatment of Seizure Clusters in Pediatric Patients Ages 2-5 Years

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Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful...
Wednesday, September 18, 2024

FDA Approves Vafseo (vadadustat) for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients on Dialysis

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Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney dise...
Tuesday, September 17, 2024

FDA Approves Duvyzat (givinostat) for Duchenne Muscular Dystrophy

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Italfarmaco S.p.A.  announced today that the  U.S. Food and Drug Administration (FDA)  has approved Duvyzat™ (givinostat), a novel histone d...
Monday, September 16, 2024

FDA Approves Opsynvi (macitentan and tadalafil) for Adults with Pulmonary Arterial Hypertension

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Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved Opsynvi ®  – a single-tablet combination...
Friday, September 13, 2024

FDA Approves Rezenopy (naloxone hydrochloride) Nasal Spray for the Emergency Treatment of Opioid Overdose

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The U.S. Food and Drug Administration has approved Rezenopy (naloxone hydrochloride) nasal spray 10 mg for emergency treatment of known or s...
Thursday, September 12, 2024

FDA Approves Tryvio (aprocitentan) for the Combination Treatment of Resistant Hypertension

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Idorsia Pharmaceuticals U.S. Inc. announced the US Food and Drug Administration (FDA) approval of  Tryvio™ (aprocitentan) for the treatment ...