• Wed news: BioNTech buying Biotheus. FDA’s Califf lists hopes for his successor. Amgen loses $12B market cap from hidden spreadsheet tab. TRex Bio raises $84M. London is Europe’s life science capitol. See more on our front page

FDA Advisory Committee Recommends Ipsen's Palovarotene as an Effective and Safe...

Quote
cafead

cafead

Administrator
Staff member
  • cafead   Jun 28, 2023 at 10:32: PM
via
  • Advisory committee voted 10 for and 4 against that evidence from the Phase III MOVE study show palovarotene is an effective treatment in patients with the ultra-rare bone disease fibrodysplasia ossificans progressiva (FOP)
  • Advisory committee further voted 11 for and 3 against on the benefits of palovarotene outweighing the risks, for the treatment of patients with FOP
  • FDA PDUFA action date is anticipated by August 16, 2023

article source
 




Top Bottom
Back
Quote