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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Supplemental Filings: Ycanth Approved For Molluscum; CDER Counter-Terrorism Head Retires; 5 Benzodiazepines Added To Schedule I
The fourth review cycle is the charm for Verrica's cantharidin topical solution; Rosemary Roberts, head of CDER's Counter-Terrorism and Emergency Coordination Staff, retires after 35 years at the FDA; DEA deems five designer benzodiazepines with no currently accepted medical use in the US as Schedule I controlled substances.
Verrica’s Ycanth, a drug-device combination product containing a formulation of cantharidin, is approved by the FDA as the first treatment for molluscum, after three complete response letters.
FDA action is expected on a handful of novel agents, including Daiichi Sankyo’s quizartinib, and conversion to full approval for Eisai/Biogen’s Leqembi.