T he Food and Drug Administration said on Friday that it has some safety concerns about an experimental CRISPR-based treatment for sickle cell disease, citing the methods used by its makers to ...

Dozens of lawmakers are urging US health regulators to crack down on the booming market for knockoff weight-loss drugs amid ...

The FDA is still on track to meet its user fee targets despite a higher-than-normal vacancy rate among scientific reviewers.

Commissioner Marty Makary said in an interview with Politico’s Dasha Burns that the FDA will “look at the data” surrounding ...

The FDA has been approving new drugs so quickly that some patient safety advocates are voicing concerns, according to Bloomberg. The FDA has 10 months to approve or deny a drugmakers ...

In briefing documents released ahead of an Advisory Committee meeting this week, FDA staffers cited safety risks related to a ...

By addressing safety, labeling, misleading claims, and adulteration concerns, DAP enables the FDA to track, authorize and regulate the sale of cannabis-derived products and accelerates CDPs entry ...

The drugs that gained FDA approval right before the deadline for their review were more likely to have post-market safety issues. On the flip-side, drugs with the quickest approvals (under 200 ...

FDA panel rejects drug that could combat rare terminal illness 02:40 "Some people might think it's alarming that one in three drugs are having a safety problem after approval.If you believe this ...

New drugs are generally tested first in hundreds or even thousands of people for safety and effectiveness. “We know that safety concerns, new ones, are going to be identified once a drug is used ...

Nearly one out of every three drugs approved by the Food and Drug Administration (FDA) have a new safety issue detected in the years after approval, says a Yale-led study.While most of the safety ...