Keeping Track: Tumor-Agnostic Approval For Novartis; Submissions From Krystal, Menarini, And Astellas
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
You may also be interested in...
Keeping Track: Showers Of Approvals In US FDA’s May Forecast
Upcoming user fees include 16 novel agents, featuring two RSV vaccines, two gene therapies, and three oncologics. The Pink Sheet’s US FDA Performance Tracker breaks down the big month to come.
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.
Keeping Track: Axsome’s Auvelity Survives Long Review; Bluebird’s Zynteglo Cleared For Liftoff; Omeros Appeals CRL
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker