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FDA Shares Rejection Letters Drugmakers Often Kept Secret
The US Food and Drug Administration is starting to publish letters the agency sent to pharmaceutical companies when their ...
BioPharma Dive25m
FDA, in policy shift, publishes some drug rejection letters
The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...
BioSpace44m
FDA Publishes Cache of Complete Response Letters in Bid for ‘Radical Transparency’
The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...
Fierce Biotech1h
FDA releases ‘initial batch’ of more than 200 drug rejection letters
The FDA has released an "initial batch" of 200 complete response letters (CRLs) in efforts to boost transparency. | The FDA has released an "initial batch" of 200 complete response letters (CRLs) in ...
US FDA publishes 200 complete response letters from archive in transparency drive
The U.S. Food and Drug Administration released more than 200 of its so-called complete response letters from its archive on ...
STAT1h
FDA publishes rejection letters sent to drugmakers, with a big caveat
The FDA published more than 200 letters that it sent to companies when it rejected their medicines, but the letters came with a caveat.
FDA Publishing Complete Response Letters to Boost Transparency
The FDA on Thursday said it published more than 200 decision letters, known as complete response letters, that it issued in response to applications for approval of drugs or biological products ...
FDA publishes more than 200 rejection letters in a bid to improve transparency
The U.S. FDA publishes over 200 complete response letters to enhance transparency within the agency. Read more here.
US FDA publishes 200 rejection letters in transparency push
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.
Moderna wins full FDA approval for COVID shot in children
Moderna (MRNA) stock rises as the company's Spikevax COVID-19 vaccine gets FDA approval for kids 6 months-11 years at higher ...
Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine, Spikevax, in Children Aged 6 Months Through 11 Years at Increased Risk for COVID-19 Disease
Spikevax is now approved for all adults aged 65 years and older, and individuals aged 6 months through 64 years at increased risk for COVID-19 disease CAMBRIDGE, MA / ACCESS Newswire / July 10, 2025 / ...