For selected applicants, the agency plans to cut review times down to one to two months and provide "tumor board-style" ...

Qualifying manufacturers will be able to submit some data while clinical trials are ongoing. Marty Makary is the commissioner ...

AI, a global leader in AI-powered cardiovascular diagnostics, announced today that the Pharmaceuticals and Medical Devices ...

“We are thrilled to receive Fast Track designation from the FDA for FNP-223 in the treatment of PSP. Consistent with our ...

Kraft said that it will instead use natural colors for impacted products sold under brands including Crystal Light, Kool Aid, Jell-O and Jet Puffed.

"We are thrilled to receive Fast Track designation from the FDA for FNP-223 in the treatment of PSP. Consistent with our ...

AI, pioneer of AI-based FFR "AutocathFFR" software, today announced a distribution agreement with Terumo Corporation to ...

Mentis, a company developing an innovative diagnostic support technology in mental health, recognized by the U.S. Food and ...

When two of medicine’s most outspoken reformers publish a roadmap for the FDA, you expect at least coherence. Instead, we get ...

The Food and Drug Administration (FDA) is looking to AI to solve the problem of lengthy approval processes, as the Trump administration invests in even more automation amid thousands of federal worker ...

Learn more about the generative AI technology that will be used at the Food and Drug Administration (FDA) to speed up reviews ...