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The U.S. Food and Drug Administration released more than 200 of its so-called complete response letters from its archive on ...
The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...
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.
US regulators approved Moderna Inc.’s Covid vaccine for children, but for a narrower group than before, continuing Robert F.
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 / ...
Investors have long asked the FDA to share its reasons for rejecting drugs, arguing that companies can use the agency’s silence on the matter to mislead the market.
Used for diagnosing gastroesophageal reflux, the devices may not attach or detach correctly, potentially causing serious ...
In discussions with multiple potential animal health company partners to collaborate to bring Canalevia®, conditionally ...
Cognition Therapeutics shares surged after the clinical-stage company said it completed the end-of-Phase 2 meeting with the Food and Drug Administration for its zervimesine drug. Shares were up 30% at ...
Beyond staff cuts, the departures of some longtime investigators in recent months have left less experienced people tasked ...
WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...
Weaver Nut Company, Inc. announced a recall for specific lots of its semi-sweet chocolate nonpareils on June 17 due to the undeclared presence of milk.