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.
Keeping Track: US FDA Clears Vtama, But Not Bimekizumab Or Ycanth; Tibsovo Takes RTOR To Frontline AML Setting
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.