Announced via FDA Office of Media Affairs email 11:04 a.m.
FDA’s Busy Day
FDA clears AbbVie’s Technivie, Novartis’ Odomzo, a new indication for Amgen’s Kyprolis and Bristol’s Daklinza July 24 before its much anticipated approval of Regeneron/Sanofi’s Praluent.
Announced via FDA Office of Media Affairs email 11:04 a.m.
FDA’s Busy Day
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.
The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.