News

FDA Authorizes First AI Platform for Breast Cancer Prediction
Platform can help predict a woman's five-year risk for developing breast cancer by analyzing routine mammograms ...
STAT20h
FDA reassures rare disease advocates that ‘being flexible’ is plan for gene therapy
Trump health officials signal eased FDA rules for rare disease gene therapy, but concerns linger over safety, oversight, and ...
RFK Jr. will ‘end the war’ against alternative medicine at the FDA, from stem cell therapy to chelation. Here’s what to know
Kennedy, Jr. doubled down on his support for non-pharmaceutical health treatments during a recent podcast appearance, saying, ...
FDA rushed out agency-wide AI tool—it’s not going well
FDA staffers in the Center for Devices and Radiological Health told NBC News that their AI pilot, CDRH-GPT, is buggy, isn't ...
BioPharma Dive21h
FDA meeting gives window into gene therapy field’s angst
Gene therapy experts and advocates warning of the sector’s many challenges found a receptive audience in FDA leadership at a ...
Publix Food Recall Update as FDA Issues Arsenic Warning
An FDA Class II recall for the Publix baby food product indicates a remote but not negligible possibility of serious health ...
FDA’s New AI Tool Cuts Review Time From 3 Days To 6 Minutes
The U.S. FDA announced this week that it deployed a generative AI tool called ELSA, now in use by staff across the agency, ...
How much money will the FDA get next year?
House appropriators advanced a bill to fund the FDA for fiscal 2026 on a party-line vote out of a subcommittee Thursday — but ...