Showing posts with label FDA Approves. Show all posts
Showing posts with label FDA Approves. Show all posts
Friday, October 30, 2026

FDA Approves Xocova (ensitrelvir), the First and Only Oral Option to Help Prevent COVID-19 Following Exposure

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In continuation of my update on  ensitrelvir Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, P...
Monday, October 12, 2026

FDA Approves Trimbow (beclomethasone/formoterol/glycopyrrolate) Inhaler for the Maintenance Treatment of Asthma

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Chiesi USA, Inc. (key-A-zee), a global biopharmaceutical company,   announced   the U.S. Food and Drug Administration   approval of  Trimbow...
Wednesday, October 7, 2026

FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia

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The U.S. Food and Drug Administration has approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) ...
Saturday, September 26, 2026

FDA Approves Trimbow (beclomethasone/formoterol/glycopyrrolate) Inhaler for the Maintenance Treatment of Asthma

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In continuation of my update on beclomethasone ,  Formoterol   &  Glycopyrrolate Formoterol   beclomethasone ,  Glycopyrrolate Chiesi US...
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...