Showing posts with label FDA Approves. Show all posts
Showing posts with label FDA Approves. Show all posts
Tuesday, September 8, 2026

FDA Approves Veppanu (vepdegestrant) for the Treatment of ESR1m, ER+/HER2- Advanced Breast Cancer

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Arvinas, Inc. (Nasdaq: ARVN), with its partner Pfizer Inc. (NYSE: PFE), announced  the U.S. Food and Drug Administration (FDA)    approval f...
Monday, August 31, 2026

FDA Approves Idvynso (doravirine and islatravir) for the Treatment of HIV-1 Infection in Adults

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In continuation of my update on   Doravirine Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced the U.S. Foo...
Monday, August 17, 2026

FDA Approves Revtorpyk (gedatolisib) for the Treatment of HR+/HER2-, PIK3CA Wild-Type Locally Advanced or Metastatic Breast Cancer

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Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for multiple solid tumor ...
Friday, July 17, 2026

FDA Approves Nereus (tradipitant) for the Prevention of Motion Sickness

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Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration has approved Nereus (tradipitan...
Thursday, July 16, 2026

FDA Approves Zycubo (copper histidinate) for Children With Menkes Disease

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Sentynl Therapeutics Inc. (“Sentynl”), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences Limited (“Zydus Group”), an...
Wednesday, July 15, 2026

FDA Approves Zycubo (copper histidinate) for Children With Menkes Disease

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Sentynl Therapeutics Inc. (“Sentynl”), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences Limited (“Zydus Group”), an...
Tuesday, July 14, 2026

FDA Approves Yuvezzi (carbachol and brimonidine tartrate) Ophthalmic Solution to Treat Presbyopia

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Tenpoint Therapeutics, Ltd., a global, commercial biotechnology company focused on developing groundbreaking treatments to improve vision in...
Monday, July 6, 2026

FDA Approves Lynavoy (linerixibat) for Cholestatic Pruritus in Patients with Primary Biliary Cholangitis

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GSK  announced   the US Food and Drug Administration (FDA)  approval of  Lynavoy (linerixibat) for the treatment of cholestatic pruritus in ...
Friday, May 29, 2026

FDA Approves Rhapsido (remibrutinib) for the Treatment of Chronic Spontaneous Urticaria

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Novartis announced today that Rhapsido (remibrutinib) received US Food and Drug Administration (FDA) approval as an oral treatment for adult...
Wednesday, May 27, 2026

FDA Approves Foundayo (orforglipron), the Only GLP-1 Pill for Weight Loss That Can be Taken Any Time of Day Without Food or Water Restrictions

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Eli Lilly and Company (NYSE: LLY)  announced the FDA approval of   Foundayo™ (orforglipron) for adults with obesity, or overweight with weig...
Wednesday, May 20, 2026

FDA Approves Jascayd (nerandomilast) to Treat Idiopathic Pulmonary Fibrosis

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Boehringer Ingelheim’s Jascayd (nerandomilast) tablets has been approved by the U.S. Food and Drug Administration (FDA) as an oral treatment...
Thursday, May 14, 2026

FDA Approves Ferabright (ferumoxytol injection) Contrast Agent for Magnetic Resonance Imaging of the Brain

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Azurity Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA)  approval of  Ferabright (ferumoxytol injection), the fi...
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...