A 3-Month Delay For A Better Label: US FDA User Fee Goal Extensions Are Usually Good News
Pink Sheet analysis finds big jump in the share of novel approvals that received PDUFA extensions, largely driven by clinical and safety data submissions.
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GSK remains confident of approval despite the delay, with hopes of blockbuster sales for its myelofibrosis candidate.
The drug could nevertheless find itself in a competitive position if approved for frontline FLT3-ITD acute myeloid leukemia, especially as competitor Astellas’s Xospata has repeatedly stumbled.
Keeping Track: Travere’s Filspari, Chiesi’s Lamzede, Apellis’ Syfovre Headline US FDA Approvals; CRLs For Phathom, Biocon
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.