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The FDA published more than 200 letters that it sent to companies when it rejected their medicines, but the letters came with a caveat.
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.
The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...
The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...
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 ...
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 ...
The U.S. Phase 2 trial aims to evaluate efficacy and safety of CX11 in doses up to 200 mg and different titration schemesThe trial is expected to enroll 250 patients to receive treatment over 36 ...
In his letter, Jones rebuked Kennedy's attacks on his staff as unfounded. "The foods program staff at FDA is the envy of the world in its technical, professional and ethical standards," Jones said.
WASHINGTON — The Food and Drug Administration has authorized a not-for-profit company in California to proceed with clinical trials to study the effectiveness of smoking cannabis to treat post ...
The Food and Drug Administration (FDA) issued a “Study May Proceed” letter, allowing a phase 3 trial to evaluate first-line treatment with amezalpat (TPST-1120) in combination with the current ...
TAIPEI and SAN DIEGO, Oct. 14, 2024 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and ...
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