I don’t think they’re needed,” said George Tidmarsh, head of the FDA’s Center for Drug Evaluation and Research.

The purpose of the list is to keep unverified and unapproved GLP-1 drug ingredients from entering the country.

Many in Central Florida were left puzzled after the U.S. Food and Drug Administration approved more restrictive measures for ...

The US Food and Drug Administration approved updated Covid-19 vaccines but for a more limited group: adults age 65 and older ...

While the new framework signals continued flexibility at the FDA regarding rare disease approvals, some analysts and ...

The FDA’s decision not to authorize COVID-19 vaccines for healthy children has drawn criticism. Some argue: If parents want ...

If you're not over 65 or have certain risk factors, it might be hard to get one but not necessarily impossible. Here's what ...

COVID vaccines have been approved for use in seniors and some adults and children with underlying health conditions ...

WASHINGTON (AP) — U.S. regulators approved Pfizer’s updated COVID-19 shot Wednesday but with limits that could complicate access for millions of American adults and children.

Omeros’ efforts to get its transplant drug to market have already suffered one FDA rejection. Now, the biotech’s second shot at approval has been pushed back by three months. Omeros had been given a ...