Keeping Track: US FDA Clears Vtama, But Not Bimekizumab Or Ycanth; Tibsovo Takes RTOR To Frontline AML Setting
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
You may also be interested in...
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 Finally Gets Molluscum Treatment To The Finish Line
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.
Cool Down: US FDA’s July User Fee Calendar Suggests Slower Pace After Torrid June
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.