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 ...

The U.S. Food and Drug Administration extended the review of KalVista Pharmaceuticals' drug for a type of hereditary swelling ...

While it is not the most common allergy in the country, almost 2 million Americans have an allergy to soy, according to Food ...

The U.S. Food and Drug Administration on Thursday approved UroGen Pharma's drug to treat a type of bladder cancer, providing ...

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

The new FDA commissioner and Center for Biologics Evaluation and Research (CBER) director laid out their vision for the ...

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

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

With a Trump-driven reduction of nearly 2,000 employees, agency officials view artificial intelligence as a way to speed ...

The FDA approved intravesical mitomycin in non–muscle-invasive bladder cancer as an nonsurgical alternative to transurethral ...

The U.S. Food and Drug Administration (FDA) says it plans to use artificial intelligence (AI) to help speed the approval of ...