Showing posts with label FDA approval. Show all posts
Showing posts with label FDA approval. Show all posts
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...
Monday, January 23, 2023

FDA Approves Iyuzeh (latanoprost ophthalmic solution) for the Reduction of Elevated Intraocular Pressure (IOP) in Patients with Open-Angle Glaucoma or Ocular Hypertension

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In continuation of my update on  Latanoprost Thea Pharma, Inc.  (“Thea”), the U.S. subsidiary of Europe’s leading independent pharmaceutical...
Friday, January 20, 2023

FDA Approves Rezlidhia (olutasidenib) for Relapsed or Refractory Acute Myeloid Leukemia with a Susceptible IDH1 Mutation

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Rigel Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA)  approval  of  Rezlidhia (olutasidenib) capsules for the t...
Thursday, January 19, 2023

FDA Approves Krazati (adagrasib) for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with a KRASG12C Mutation

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Mirati Therapeutics, Inc.   (NASDAQ: MRTX), a targeted oncology company, announced the U.S. Food and Drug Administration (FDA)  approval of ...
Wednesday, January 18, 2023

FDA Approves Olpruva (sodium phenylbutyrate) for Patients with Urea Cycle Disorders

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In continuation of my update on Phenyl butyrate   Acer Therapeutics Inc. and its collaboration partner, RELIEF THERAPEUTICS Holding SA (“Rel...