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 ...

Sevabertinib showed promise in early trials for non-squamous non-small-cell lung cancer with HER2 mutations. Read more at ...

Dec 9 (Reuters) - The U.S. Food and Drug Administration approved on Tuesday the first drug under its new fast-track program ...

Dec 8 (Reuters) - The U.S. Food and Drug Administration has qualified the first artificial intelligence tool designed to help ...

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 ...

As the U.S. works several levers to lower drug pricing, such as Medicare negotiating costs with drugmakers and President Donald Trump launching TrumpRx, a report from the IQVIA Institute quantified ...