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 [...]

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. [...]

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 [...]

Europe—not US—first to authorize Moderna's combo mRNA flu-COVID vaccine

Amid RFK Jr.'s anti-vaccine agenda, Moderna withdrew its FDA application last year. [...]

FDA refuses to review Moderna's mRNA flu vaccine

The move comes amid RFK Jr.'s relentless efforts to enact his anti-vaccine agenda. [...]

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 [...]

Flick Shot Rogues is the rare turn-based game that my brain is gelling with

Try as I might, turn-based strategy games don't usually do it for me. That's one reason I haven't yet dipped into Clair Obscur: Expedition 33, many people's favorite of the year so [...]

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 [...]

Trump official overruled FDA scientists to reject Moderna's flu shot

FDA's top vaccine regulator, Vinay Prasad, is known for overruling scientists. [...]