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, June 16, 2025

FDA Grants Accelerated Approval for Vanrafia (atrasentan) for Proteinuria Reduction in Primary IgA Nephropathy

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Novartis  announced the US Food and Drug Administration (FDA)  accelerated approval for Vanrafia ®  (atrasentan), a potent and selective end...
Saturday, June 14, 2025

FDA Approves Mezofy (aripiprazole) Oral Film for the Treatment of Schizophrenia

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In continuation of my update on Aripiprazole CMG Pharmaceuticals, an affiliate of Cha Biotech, announced on the 16th that it had received pr...
Thursday, June 12, 2025

FDA Approves Atzumi (dihydroergotamine) Nasal Powder for the Acute Treatment of Migraine

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Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395),  announced  the U.S. Food and Drug Administration (FDA) approval of    New Drug Applic...
Tuesday, October 8, 2024

FDA Approves Tepylute (thiotepa) Ready-to-Dilute Injectable Formulation to Treat Breast Cancer and Ovarian Cancer

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Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA...
Monday, October 7, 2024

FDA Approves Ohtuvayre (ensifentrine) for the Maintenance Treatment of Chronic Obstructive Pulmonary Disease (COPD)

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Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces the US Food and Drug Administration (“FDA”) approved Ohtuvayr...
Saturday, October 5, 2024

FDA Approves Sofdra (sofpironium) Topical Gel for the Treatment of Primary Axillary Hyperhidrosis

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Clinical dermatology company, Botanix Pharmaceuticals Ltd. (ASX:BOT, Botanix or the Company), is pleased to announce the US Food and Drug Ad...
Friday, October 4, 2024

FDA Approves Vigafyde (vigabatrin) as the First and Only Ready-to-Use Vigabatrin Oral Solution

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Pyros Pharmaceuticals, Inc. (Pyros or the Company), a leader in the development of enhanced specialty pharmaceuticals for rare diseases, ann...
Thursday, October 3, 2024

FDA Grants Accelerated Approval to Iqirvo (elafibranor) for the Treatment of Primary Biliary Cholangitis

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Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Iqir...