Keeping Track: Axsome’s Auvelity Survives Long Review; Bluebird’s Zynteglo Cleared For Liftoff; Omeros Appeals CRL
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Genentech’s Polivy To Get US FDA Panel Review For First-Line Treatment Of Diffuse B-Cell Lymphoma
But company says the 9 March advisory committee meeting ‘currently does not have any impact’ on Polivy’s existing accelerated approval indication in the third-line setting; agency may be seeking input on the robustness of the progression-free survival benefit and uncertainties about overall survival data in the POLARIX Phase III trial in previously untreated DLBCL.
New EU Filings Include First Self-Administered Treatment For Myasthenia Gravis
UCB’s zilucoplan for treating gMG is among the latest new drugs that the European Medicines Agency has started reviewing for potential EU marketing approval.
As Vaccines Pipeline Gushes, Complex Communication Challenges Loom
CDC Advisory Committee on Immunization Practices prepares for expected US FDA approvals of new vaccines to prevent respiratory syncytial virus in older adults, chikungunya and dengue and clarified recommendations for high-valent pneumococcal vaccines.