KalVista Pharmaceuticals' said on Friday that the U.S. Food and Drug Administration had extended the review of its drug for a ...

The FDA expanded its approval of Moderna's RSV vaccine on Thursday to include adults under age 60 at increased risk of the ...

The U.S. Food and Drug Administration on Thursday expanded the use of Moderna's respiratory syncytial virus vaccine to a ...

To obtain full approval of the drug for treatment of chemotherapy-induced diarrhea (CID) and to expand the indication of ...

Expanded indication builds on existing U.S. FDA approval of mRESVIA for adults aged 60 and older CAMBRIDGE, MA / ACCESS ...

A new article in the Journal of the American Medical Association said the FDA will implement AI into multiple processes.

The NDIN review process follows the Federal Food, Drug, and Cosmetic Act (the FD&C Act) requirement that manufacturers and ...

Yesterday, the New York Times reported that the FDA, in collaboration with USDA and other government agencies, plans to ...

AD04 is Adial's lead investigational drug, a serotonin-3 receptor antagonist, being developed for the treatment of Alcohol ...

MENLO PARK, Calif., June 16, 2025 (GLOBE NEWSWIRE) -- Inquis Medical, the leading innovator in the treatment of venous ...

The FDA plans to "unleash AI" on new drug evaluations in order to "radically increase efficiency in the review process." ...

In today's Pharmalittle roundup, we're reading about a Sarepta setback with its Duchenne drug, the FDA workload causing a ...