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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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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.

Neurocrine Will Delay Ongentys Launch, But It Thinks Differentiation Is Clear

Ongentys, now approved as adjunctive therapy in Parkinson’s disease, will offer a convenience advantage over generic COMT inhibitors. The company will delay launch due to pandemic and manufacturing issues.

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