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...
Thursday, October 30, 2025

FDA Approves Inluriyo (imlunestrant) for Adults with ER+, HER2-, ESR1-Mutated Advanced or Metastatic Breast Cancer

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Eli Lilly and Company (NYSE: LLY) announced  the U.S. Food and Drug Administration (FDA)  approval of  Inluriyo (imlunestrant, 200 mg tablet...
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 ...
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...