The FDA Fast Track process features regular interactions with the FDA, including the potential for early and rolling review ...

“The FDA recognizes that there’s a problem, so they have begun to formulate a plan to put a system in place, and they made ...

PTC Therapeutics will also get the FDA's priority review voucher, which allows a drug developer to expedite the review ...

In a long-sought move, the Food and Drug Administration on Thursday formally began the process of abandoning oral doses of a ...

A researcher has filed a lawsuit against the Drug Enforcement Administration, accusing the agency of multiple legal ...

The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...

The Food and Drug Administration (FDA) is proposing the removal from the market of a common ingredient found in most oral ...

Medical experts who’ve studied the experimental treatment program, however, say there’s no evidence to support Trump’s claims ...

In the pursuit of youthful aging and vitality, many individuals find themselves exploring various supplements and health ...

The Food and Drug Administration (FDA) is proposing to officially remove a popular ingredient in many cold and allergy ...

Up until now, drivers who have a failed drug or alcohol test reported to the Clearinghouse ... of “prohibited” status by ...

Developer Autolus set a list price of $525,000 for its new cell therapy, which it will sell for a type of leukemia under the ...