pharmaphorum1d
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 ...
Nasdaq7d
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 Alpha25d
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 ...
Consumer price index report and Juan Soto's free agency: Morning Rundown
Plus, Donald Trump is set to visit the White House to meet with President Joe Biden for a symbolic meeting to signify a ...
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 ...
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 ...
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 ...
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 Finance7d
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 ...