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Pharma News for GSK, Roche, Eli Lilly, Coherus
Phase III RUBY Trial of Jemperli Plus Chemotherapy Updates; FDA Approves Roche’s Vabysmo for RVO; FDA Grants Priority Review to Tovorafenib Low-Grade Glioma; FDA Approves Lilly’s Omvoh; FDA Approves Toripalimab for Nasopharyngeal Carcinoma; FDA Fast Track Designation to ONCT-534 R/R mCRPC

FDA Granted Fast Track Designation to Oncternal Therapeutics’s ONCT-534 for the Treatment of Metastatic Castration-Resistant Prostate Cancer On Oct. 26, 2023, Oncternal Therapeutics, Inc. (Nasdaq: ONCT) announced that the U.S. Food and Drug Administration (FDA) has designated ONCT-534, its novel dual-acting andr...

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Pharma News for GSK, Biogen, Citius
FDA Expands GSK’s Jemperli Approval; Biogen to Acquire Reata Pharma; Enhertu Shows Survival Boost in HER2+ Solid Tumors; FDA Rejects Citius’ Revived IL-2 Therapy; FDA Fast Track designation to IVS-3001 for RCC; EU Orphan Drug Designation to Biohaven’s Taldefgrobep Alfa

FDA Expands GSK’s Jemperli Approval for Endometrial Cancer GSK plc announced that the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with mismatch repair deficient...

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Pharma News Updates for Merck, Sanofi, GSK, Hinova, Endogena, Amylyx
Merck’s Keytruda Wins Another FDA Approval; Sanofi Pauses Trial of Myasthenia Gravis Drug, tolebrutinib; FDA Approves GlaxoSmithKline’s Jesduvroq; FDA IND Application Clearance for Hinova’s HP518; FDA Fast Track Designation to Endogena’s EA-2353; Amylyx Updates on Global Phase 3 PHOENIX Trial

Merck Wins Another FDA Approval for Blockbuster Keytruda Merck & Co arrived just two months after GSK celebrated a positive phase III result with its checkpoint inhibitor Jemperli as a first-line therapy for endometrial cancer. Keytruda (pembrolizumab) from Merck improved progression-free survival (PFS) vers...

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