Commissioner Robert Califf’s comments offer further context for FDA’s unprecedented decision to reconvene an advisory committee for a second review of Amylyx’ AMX0035 for ALS.

Attorneys say the biggest step FDA could take to expand access to medication abortion would be to eliminate REMS requirement for mifepristone. Timeline notes steps Biden administration and Congress have taken since the Supreme Court’s ruling overturning the right to an abortion.

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

England’s health technology appraisal body NICE has recommended Galapagos’ Jyseleca for ulcerative colitis, Takeda’s Revestive for short bowel syndrome and Zogenix’s Fintepla for seizures associated with Dravet syndrome.