FDA does U-turn, will review Moderna's mRNA flu shot after shocking rejection

Trump admin's vaccine chief overruled FDA scientists to initially reject the shot. [...]

The FDA rolls out its own AI to speed up clinical reviews and scientific evaluations

The FDA has launched the generative AI tool, Elsa, agency-wide to help its employees with everything from clinical reviews to investigations. Sure, we're living in a time of widespread disinforma [...]

Big Tech bent the knee for Trump in 2025

Sure, we've seen millions poured into lobbying and other means of influence during every presidency, but the last two years set a whole new bar. Business leaders, including those from almost ever [...]

Moderna and other vaccines stocks are down after the FDA's top vaccine official resigns

Moderna (MRNA) and other vaccine maker stocks plummeted during pre-market trading on Monday amid news from this weekend that the Food and Drug Administration’s (FDA) top vaccine regulator was forced [...]

Trump administration adds note rejecting 'gender ideology' to government websites

Newly restored pages on the websites of government agencies like the Food and Drug Administration (FDA) and Substance Abuse and Mental Health Services Administration (SAMHSA) now include a disclaimer [...]

Moderna says mRNA flu vaccine sailed through trial, beating standard shot

Moderna hailed the results, but the shot's future under RFK Jr. is murky. [...]

FDA employees say the agency's Elsa generative AI hallucinates entire studies

Current and former members of the FDA told CNN about issues with the Elsa generative AI tool unveiled by the federal agency last month. Three employees said that in practice, Elsa has hallucinated non [...]

The FDA and EU clear Nuance Audio, smart glasses with built-in hearing aids, for sale

Nuance Audio, new "hearing glasses" from EssilorLuxottica, have received FDA clearance and "a CE marking under the Medical Devices regulation in the EU," making them officially rea [...]

Apple Watch Series 11 receives FDA clearance for hypertension alerts

Apple's Awe Dropping event started with dramatic health testimonials from Apple Watch users, then revealed a key new feature for the new Watch Series 11: hypertension alerts. The function had yet [...]