News

FDA to consider drug affordability when granting new vouchers to speed up approvals, Makary says
It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...
FDA Commissioner: ‘We want to focus on food’
Makary, a surgical oncologist tapped by President Trump to serve as the the 27th FDA chief, joined NewsNation on Thursday to ...
FDA mulls faster drug reviews in exchange for lower prices in U.S.- Bloomberg
FDA Commissioner Marty Makary said during an interview with Bloomberg Television that his agency may expedite reviews of ...
BioSpace2h
FDA’s Rejections: We Read 200 CRLs So You Don’t Have To
A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...
STAT1h
FDA rejects Capricor’s cell therapy for Duchenne muscular dystrophy
The FDA rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics, as a larger study of the treatment ...
FDA publishes full texts of response letters to drug applications
The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...
Healio1h
FDA accepts new supplemental biologics license application for review for Winrevair
The FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with ...
Ritz Crackers Recalled by FDA Due to Undeclared Allergen
Several bulk boxes of Ritz cracker sandwich sleeves were recalled by their manufacturer and the FDA. Some peanut ...
US FDA declines to approve Capricor's muscle disorder therapy
Capricor Therapeutics said on Friday the U.S. Food and Drug Administration has declined to approve its cell therapy deramiocel for a heart condition associated with Duchenne muscular dystrophy.
STAT3d
Inside the staff exodus and tanking morale that threaten Makary’s FDA
WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...