FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.

Lab-grown salmon is now FDA approved — here’s why this one restaurant is putting it on the menu By Caroline Cubbin Published June 10, 2025, 8:02 p.m. ET ...

The U.S. FDA announced this week that it deployed a generative AI tool called ELSA, now in use by staff across the agency, several weeks ahead of its original schedule.

Four Democrat-led states ask FDA to remove abortion pill restrictions The attorneys general of New York, California, Massachusetts and New Jersey asked the FDA to lift some requirements on ...

The FDA may be facing a 4% cut to its overall budget courtesy of the Trump administration, but that hasn’t stopped the agency from unveiling a new generative AI tool a month ahead of schedule.

The FDA launched a generative artificial intelligence (AI) tool, dubbed Elsa, designed to help employees such as scientific reviewers and investigators work more efficiently, the agency announced ...

FDA unveils ‘Elsa’ generative AI tool for staff Grandbrothers/Getty Images By Alexandra Kelley June 3, 2025 ...

GOP Rep. Marjorie Taylor Greene of Georgia, an outspoken COVID-19 vaccine critic, blasted the FDA's green lighting of the mNEXSPIKE as "Not MAHA at all!!!" in a tweet ...

Maharashtra's food safety regulator, the Food and Drug Administration (FDA), has suspended quick commerce platform Zepto's food business licence in Mumbai's Dharavi area, over reasons of non ...

The FDA has updated an ongoing recall of tomatoes distributed in Georgia, North Carolina and South Carolina to Class I—its highest warning level, The New York Times reported. A Class I recall ...

The new vaccine, mNexspike, is a step toward next-generation coronavirus vaccines. It's made in a way that allows for a lower dose — a fifth of the dose of its current COVID-19 vaccine, Spikevax ...

READ: FDA promises to cut by half approval time for new products No hike for decades The rate of fees and charges of the FDA has not been updated for more than 20 years since the implementation of ...