News

F.D.A. Posts Collection of Letters Outlining Concerns About New Drugs
The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.
STAT2h
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.
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 / ...
Indianapolis Business Journal7h
FDA begins sharing rejection letters drugmakers often kept secret
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.
BioPharma Dive7h
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 ...
BioSpace7h
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 Biotech8h
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 ...
KXAN2mon
CORXEL Receives Study May Proceed Letter from the U.S. FDA for the Phase 2 Trial of CX11 in Patients with Obesity and Overweight Conditions - KXAN Austin
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 ...
CBS News4mon
Top FDA food safety official's resignation letter warns firings will backfire on RFK Jr. - CBS News
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.
Stars and Stripes7mon
FDA authorizes clinical trials to study cannabis use for veterans with PTSD - Stars and Stripes
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 ...
Cure Today7mon
A Phase 3 Trial of Amezalpat in Advanced Liver Cancer Receives Study May Proceed Letter
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 ...
Stockhouse8mon
US FDA issues Study May Proceed letter for the Pilot Study of Pidnarulex Pharmacodynamics in Patients with Advanced Solid Tumors, Sponsored by the US National ... - Stockhouse
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 ...