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Keeping Track: US FDA Clears Vtama, But Not Bimekizumab Or Ycanth; Tibsovo Takes RTOR To Frontline AML Setting

 
• By Bridget Silverman

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Keeping Track Feature image

The US FDA approved one new molecular entity (Dermavant Sciences Inc.’s Vtama) but issued complete response letters to two other NMEs (UCB S.A.’s bimekizumab and Verrica Pharmaceuticals, Inc.’s Ycanth) last week.

While the three recent NME actions were for standard review applications, the FDA’s supplemental approvals took a higher priority. The...

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