medtechdive3h
FDA breakthrough device decisions rebound after recent declines
The FDA designated 166 products under its breakthrough devices program in its most recent financial year, reversing the ...
pharmaphorum2d
FDA ‘breakthrough’ status – a new tool for building oncology brands?
The FDA's new Breakthrough Therapy designation may offer oncology brands a powerful way forward – and some challenges for market research. Phase III in oncology – between a rock and a hard ...
Johnson & Johnson: FDA grants nipocalimab Breakthrough Therapy designation
Johnson & Johnson announced that the U.S. Food and Drug Administration has granted nipocalimab Breakthrough Therapy designation for the ...
Nasdaq8d
FDA Grants Breakthrough Device Designation for SeaStar Medical’s Selective Cytopheretic Device for Adults Undergoing Chronic Dialysis
“This is our first Breakthrough Device Designation award for the SCD in a chronic indication. We appreciate the FDA’s continued recognition of the SCD’s potential to save lives and improve ...
Seeking Alpha26d
Sagimet Soars: FDA Breakthrough Therapy Designation And Lancet Review Validate Denifanstat
Sagimet Biosciences' Denifanstat shows significant potential in treating MASH, with FDA Breakthrough Therapy designation and peer-reviewed validation, supporting a "Strong Buy" rating. Denifanstat ...
MarketWatch1mon
Ultragenyx Pharmaceutical's Bone Disease Drug Gets FDA's Breakthrough Therapy Designation
The breakthrough therapy designation allows the company to speed up the development and review of drugs which can help treat serious conditions. The FDA's decision as based on preliminary clinical ...
Yahoo Finance1mon
RARE's Bone Disorder Drug Gets FDA's Breakthrough Therapy Tag
Ultragenyx Pharmaceutical RARE announced that the FDA has granted the Breakthrough Therapy designation to its investigational candidate, setrusumab (UX143), as a treatment to reduce the risk of ...
MarketWatch1mon
Mirum Pharmaceuticals' Volixibat Gets Breakthrough Therapy Designation from FDA
Mirum Pharmaceuticals's volixibat was granted breakthrough therapy designation by the Food and Drug Administration as a potential treatment for cholestatic pruritus for those with primary biliary ...
Business Wire1mon
Volixibat Granted Breakthrough Therapy Designation for Cholestatic Pruritus in Primary Biliary Cholangitis
today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to volixibat as a potential treatment for cholestatic pruritus in patients with ...
Financial Post1mon
Boehringer receives U.S. FDA Breakthrough Therapy designation and initiates two phase III trials in MASH for survodutide
The U.S. FDA Breakthrough Therapy designation is for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate or advanced fibrosis, based on ...
Yahoo Finance8d
FDA Grants Breakthrough Device Designation for SeaStar Medical’s Selective Cytopheretic Device for Adults Undergoing Chronic Dialysis
DENVER, Nov. 06, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences ...