Thursday, March 14, 2024

FDA Approves Daybue (trofinetide) for the Treatment of Rett Syndrome

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In continuation of my update on trofinetide Acadia Pharmaceuticals Inc. (Nasdaq: ACAD)  announced  the U.S. Food and Drug Administration (FD...
Monday, March 11, 2024

FDA Approves Zavzpret (zavegepant) Nasal Spray for the Acute Treatment of Migraine

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Pfizer Inc. (NYSE: PFE)  announced the U.S. Food and Drug Administration (FDA)  approval of Zavzpret (zavegepant), the first and only calcit...
Friday, March 8, 2024

FDA Approves Skyclarys (omaveloxolone) for the Treatment of Friedreich’s Ataxia

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In continuation of my update on omaveloxolone Reata Pharmaceuticals, Inc. (Nasdaq: RETA) announced   the U.S. Food and Drug Administration (...
Wednesday, March 6, 2024

FDA Approves Rezzayo (rezafungin for injection) for the Treatment of Candidemia and Invasive Candidiasis

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In continuation of my update on rezafungin Cidara Therapeutics, Inc.   and Melinta Therapeutics, LLC  announced   the U.S. Food and Drug Adm...
Monday, March 4, 2024

FDA Approves Brenzavvy (bexagliflozin) for the Treatment of Adults with Type 2 Diabetes

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TheracosBio  announced  the U.S. Food and Drug Administration (FDA)   approval of  Brenzavvy (bexagliflozin), an oral sodium-glucose cotrans...
Friday, March 1, 2024

FDA Approves Jaypirca (pirtobrutinib) for Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma

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Loxo@Lilly, the oncology unit of Eli Lilly and Company (NYSE: LLY),  announced the U.S. Food and Drug Administration (FDA) approved  Jaypirc...
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...