By Kamal Choudhury Dec 12 (Reuters) - The U.S. health regulator on Friday approved Innoviva's oral antibiotic to treat ...

The U.S. Food and Drug Administration announced it is reviewing a proposal to allow bemotrizinol in sunscreens sold in the ...

By Kamal Choudhury Dec 11 (Reuters) - The U.S. Food and Drug Administration has approved Flow Neuroscience's at-home brain ...

Dec 11 (Reuters) - The U.S. Food and Drug Administration said on Thursday it has expanded the use of GSK's Blujepa as an oral ...

For the first time in decades, the US Food and Drug Administration has signed off on new antibiotics to fight gonorrhea. The approvals come at a critical moment: The sexually transmitted infection is ...

FDA moves reshaping drug policy include fast-track programs, updated biosimilar guidance, and new rare disease approval pathways.

The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans.

Food and Drug Administration have pressed internally for reviewers to speed up their evaluation of Eli Lilly's experimental ...

A new study finds just 6% of clinical trials used to approve new drugs in the U.S. reflect the country's racial and ethnic ...

The U.S. is considering allowing bemotrizinol, a highly effective UV filter used throughout Europe and Asia, in its sunscreen products for the first time ...