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 [...]

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. [...]

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 [...]

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. [...]

mRNA cancer vaccine shows protection at 5-year follow-up, Moderna and Merck say

The vaccines are tailor-made to target each patient's unique cancer. [...]

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 [...]

Moderna CEO Responds to RFK Jr.’s Crusade Against the Covid-19 Vaccine

Speaking at a WIRED event Tuesday, Moderna CEO Stéphane Bancel said he was “encouraged” by the company’s dialogue with the FDA—but acknowledged recent setbacks. [...]