Showing posts with label Accelerated Approval. Show all posts
Showing posts with label Accelerated Approval. Show all posts
Wednesday, November 12, 2025

FDA Grants Accelerated Approval to Avmapki Fakzynja Co-Pack (avutometinib capsules/defactinib tablets) for KRAS-Mutated Recurrent Low-Grade Serous Ovarian Cancer

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Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven...
Monday, August 11, 2025

FDA Grants Accelerated Approval to Zegfrovy (sunvozertinib) for Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

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Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseas...
Monday, June 16, 2025

FDA Grants Accelerated Approval for Vanrafia (atrasentan) for Proteinuria Reduction in Primary IgA Nephropathy

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Novartis  announced the US Food and Drug Administration (FDA)  accelerated approval for Vanrafia ®  (atrasentan), a potent and selective end...
Thursday, October 3, 2024

FDA Grants Accelerated Approval to Iqirvo (elafibranor) for the Treatment of Primary Biliary Cholangitis

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Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Iqir...
Wednesday, September 11, 2024

FDA Grants Accelerated Approval for Rezdiffra (resmetirom) for the Treatment of Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH)

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Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohe...
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...