Wednesday, August 13, 2025

FDA Approves Arynta (lisdexamfetamine) Oral Solution for ADHD and Binge Eating Disorder

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In continuation of my update on  lisdexamfetamine Food and Drug Administration (FDA) has approved Azurity Pharmaceuticals' Arynta™ (lisd...
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 ...
Monday, August 11, 2025

FDA Grants Accelerated Approval to Zegfrovy (sunvozertinib) for Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

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Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseas...
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...
Thursday, July 31, 2025

GLP-1 diabetes drugs likely trump metformin for curbing dementia risk in type 2 diabetes, study finds

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In continuation of my update  " Metformin " GLP-1 receptor agonists, a class of drug used to treat type 2 diabetes, likely trump t...
Friday, July 25, 2025

FDA Approves Ibtrozi (taletrectinib) for Advanced ROS1-Positive Non-Small Cell Lung Cancer

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Nuvation Bio Inc. announced the U.S. Food and Drug Administration (FDA)  approval of  Ibtrozi (taletrectinib) for the treatment of adult pat...
Thursday, July 24, 2025

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

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UroGen Pharma Ltd. announced the U.S. Food and Drug Administration (FDA) approval of  Zusduri, the first and only FDA-approved medication fo...
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...