News
Report says Jim O'Neill's time at HHS is nearing its end
HHS Deputy Secretary Jim O'Neill – who is also head of the CDC – is said to be on the way out after a reshuffle of department leadership by RFK Jr.
News
PTC pulls file for Duchenne therapy on FDA feedback
PTC Therapeutics has abandoned its latest attempt to secure FDA approval for Duchenne muscular dystrophy treatment Translarna.
News
FDA says comparator dose scuppered Moderna's flu jab filing
The FDA has defended its decision to issue a refusal-to-file (RTF) letter for Moderna's new mRNA-based influenza vaccine.
News
Moderna cries foul as FDA blocks filing of mRNA flu shot
The FDA won't accept Moderna's filing for an mRNA-based flu vaccine, in the latest signal of the changing regulatory climate for vaccines in the US.
News
FDA kicks off review of Takeda's narcolepsy hopeful
The FDA has started a priority review of Takeda's oveporexton for sleep disorder narcolepsy, setting up a decision in the third quarter of the year.
News
Press Releases
Views & Analysis
Editor's Picks
Editor's Picks
