Showing posts with label FDA Grants. Show all posts
Showing posts with label FDA Grants. Show all posts
Thursday, April 30, 2026

FDA grants speedy approval to Eli Lilly's weight-loss pill for obesity

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Federal regulators on Wednesday approved Eli Lilly's new weight-loss pill, a second daily oral medication to treat obesity and other wei...
Tuesday, December 16, 2025

FDA Grants Accelerated Approval to Hernexeos (zongertinib) for Previously Treated Patients with HER2-Mutant Advanced NSCLC

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Boehringer Ingelheim’s Hernexeos (zongertinib tablets) has been approved by the U.S. Food and Drug Administration (FDA). The kinase inhibito...
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...
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...
Thursday, March 7, 2019

FDA Grants Priority Review for Daiichi Sankyo’s New Drug Application for CSF1R Inhibitor Pexidartinib for Treatment of Patients with TGCT, a Rare, Debilitating Tumor

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   Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and Drug Administration (FDA) has accepted a...