Thursday, February 29, 2024

FDA Approves Orserdu (elacestrant) for Patients with ESR1 Mutations in ER+, HER2- Advanced or Metastatic Breast Cancer

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The Menarini Group (“Menarini”), a leading Italian pharmaceutical and diagnostics company, announced  the U.S. Food and Drug Administration ...
Tuesday, February 27, 2024

FDA Approves Jesduvroq (daprodustat) for Anemia Caused by Chronic Kidney Disease for Adults on Dialysis

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GSK plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA)  approval of  Jesduvroq (daprodustat), an oral hypoxia-inducible...
Saturday, February 24, 2024

FDA Approves Miebo (perfluorohexyloctane) Ophthalmic Solution for the Treatment of the Signs and Symptoms of Dry Eye Disease

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Bausch + Lomb Corporation, announced that the U.S. Food and Drug Administration (FDA) has approved Miebo ™  (perfluorohexyloctane ophthalmic...
Thursday, February 22, 2024

FDA Approves Lumryz (sodium oxybate) for Cataplexy or Excessive Daytime Sleepiness in Adults with Narcolepsy

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In continuation of my update on Lumryz Avadel Pharmaceuticals plc   a biopharmaceutical company announced   the U.S. Food & Drug Adminis...
Tuesday, February 20, 2024

FDA Approves Mydcombi (tropicamide and phenylephrine hydrochloride) Ophthalmic Spray for Inducing Mydriasis

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In continuation of my update on phenylephrine hydrochloride Phenylephrine Tropicamide Eyenovia, Inc, announced  the U.S. Food and Drug Admin...
Thursday, February 15, 2024

FDA Grants Accelerated Approval for Qalsody (tofersen) for the Treatment of Amyotrophic Lateral Sclerosis Associated with a Mutation in the SOD1 Gene

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Biogen Inc. (Nasdaq: BIIB) announced the U.S. Food and Drug Administration (FDA)   approval of  Qalsody (tofersen) 100 mg/15mL injection for...
Wednesday, February 14, 2024

FDA Approves Abilify Asimtufii (aripiprazole) for the Treatment of Schizophrenia or Maintenance Monotherapy Treatment of Bipolar I Disorder in Adults

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In continuation of my update on aripiprazole Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) announced ...
Tuesday, February 13, 2024

FDA Approves Uzedy (risperidone) Extended-Release Injectable Suspension for the Treatment of Schizophrenia in Adults

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In continuation of my update on  Uzedy (risperidone) Teva Pharmaceuticals,  announced  the U.S. Food and Drug Administration (FDA)  approval...
Wednesday, February 7, 2024

FDA Grants Accelerated Approval to Filspari (sparsentan) for the Reduction of Proteinuria in IgA Nephropathy

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Travere Therapeutics, Inc. (Nasdaq: TVTX) announced  the U.S. Food and Drug Administration (FDA)  approval to  Filspari ™ (sparsentan) to re...
Saturday, February 3, 2024

FDA Approves Veozah (fezolinetant) for the Treatment of Vasomotor Symptoms Due to Menopause

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Astellas Pharma Inc. announced  the U.S. Food and Drug Administration (FDA)   approval of  Veozah (fezolinetant) 45 mg once daily for the tr...
Thursday, January 25, 2024

FDA Approves RizaFilm (rizatriptan) Oral Film for the Treatment of Acute Migraine

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In continuation of my update on  rizatriptan IntelGenx Corp. (TSX:IGX)(OTCQB:IGXT),  announced the U.S. Food and Drug Administration  approv...
Saturday, January 6, 2024

FDA Approves Joenja (leniolisib) for the Treatment of Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS)

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Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announced the USFDA  approval...