Keeping Track Of US FDA Decisions: Approvals For Ongentys And New Keytruda, Darzalex Dosing, But Not For Trevyent
Executive Summary
The latest US FDA approval decision news and highlights from the Pink Sheet’s FDA Performance Tracker
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Keeping Track: Furoscix, SPN-830 Show Difficulties Of Drug-Device Combinations
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Genentech’s Subcutaneous Tecentriq Shows Non-Inferiority To I.V. Formulation
The Roche affiliate hopes to bring subcutaneous Tecentriq to market, offering patient and clinician advantages while also beating Merck’s Keytruda and Bristol’s Opdivo to the finish line
GSK’s Zejula Wins First-Line Ovarian Cancer Use
Winning an expanded US FDA indication for Zejula as a first-line ovarian cancer treatment further vindicates GSK’s hefty purchase price for Tesaro and sets the scene for more therapeutic extensions for the PARP inhibitor, oncology R&D chief Axel Hoos told Scrip.