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It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...
Makary, a surgical oncologist tapped by President Trump to serve as the the 27th FDA chief, joined NewsNation on Thursday to ...
FDA Commissioner Marty Makary said during an interview with Bloomberg Television that his agency may expedite reviews of ...
A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...
The FDA rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics, as a larger study of the treatment ...
The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...
The FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with ...
Several bulk boxes of Ritz cracker sandwich sleeves were recalled by their manufacturer and the FDA. Some peanut ...
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.
WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...