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The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...
Capricor Therapeutics (NASDAQ:CAPR) shares fell Friday after the company announced it received a complete response letter from the U.S. Food and Drug Administration for its Biologics License ...
Capricor Therapeutics shares plummeted in premarket trading Friday after the U.S. Food and Drug Administration turned away the biotechnology company's bid for approval of Deramiocel, its lead ...
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.
The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...
The federal government's investigation into a recall of Salmonella-contaminated brown cage-free and certified-organic eggs ...
The U.S. Food and Drug Administration on Thursday published more than 200 of its so-called complete response letters to drugmakers, a significant move to increase transparency of the agency's work.
FDA approves Bravecto Quantum, the first injectable flea and tick treatment offering dogs up to 12 months of protection.
The Food and Drug Administration (FDA) granted full approval on Thursday to Moderna’s COVID-19 vaccine for children, making it the first COVID shot for kids aged 6 months to 11 years old that is ...
Beyond staff cuts, the departures of some longtime investigators in recent months have left less experienced people tasked ...
A consumer advocate named Harvey W. Wiley started the FDA in 1906, through the Pure Food and Drug Act, in part a response to the snake oil problem. Wiley also had a passion for food safety.
The Food and Drug Administration (FDA) is a government agency that is responsible for the promotion and protection of public health. The FDA was established when the Pure Food and Drugs Act was ...