Keeping Track: US FDA Approves Carvykti, Vonjo, But Turns Down Lenacapavir, Filsuvez And GC1507
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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A first-in-class capsid inhibitor, lenacapavir is a linchpin of Gilead’s long-term strategy in HIV treatment and prevention, but has faced regulatory setbacks in the US.
Keeping Track: Tumor-Agnostic Approval For Novartis; Submissions From Krystal, Menarini, And Astellas
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
The sponsors of four drugs were due or possibly due to appear before the European Medicines Agency to explain why their respective products merit EU-wide approval.