FDA
5 stories from 38 sources this week
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This week's FDA coverage balance across rated outlets
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- GSK earns FDA approval for JideytroGSK won FDA approval for Jideytro (zidesamtinib), its ROS1 inhibitor for ROS1-positive non-small cell lung cancer, ahead of the September 18 deadline as part of its Nuvalent acquisition. The treatment, showing a 44% response rate in trials, positions GSK to compete in lung cancer and supports ongoing development of additional Nuvalent assets like neladalkib and ris-rez.9 src · 2h
- Glenmark's RYALTRIS gains FDA approval for children 6–11The U.S. FDA expanded the indication for RYALTRIS to include children aged 6 to less than 12 with Seasonal Allergic Rhinitis, broadening its use alongside adults and older youths. The approval, supported by a Phase 3 trial of 446 children showing improved nasal symptoms and good tolerability, coincides with Glenmark’s plan to transition to direct U.S. commercialization by April 1, 2026.8 src · 2d
- Experimental pancreatic cancer drug now available in NebraskaDaraxonrasib, an investigational KRAS-targeting drug, has shown the potential to more than double survival in stage IV pancreatic cancer compared with chemotherapy and is being offered through expanded access programs at Nebraska Medicine, with Ben Sasse publicly discussing his positive response. The FDA has accepted an NDA for daraxonrasib based on phase 3 trial results showing significant improvements in overall survival, progression-free survival, and response rate, signaling a possible breakthrough though not yet FDA approved.7 src · 50m