FDA rates as Class 1 a Leonard Lang recall of two Skintact multifunction defibrillation electrode models due to a connector compatibility issue.
Amicus Therapeutics says top-line Phase 3 ESSENCE study data show its SD-101 wound-healing agent did not meet primary or secondary endpoints in epider...
Industry advocates challenge conclusions in a JAMA Internal Medicine analysis of the cost and potential revenue involved in developing one new cancer ...
Drug companies say FDA should do more work on its draft document on standardization of pharmaceutical quality and chemistry, manufacturing, and contro...
FDAs Medical Imaging Drugs Advisory Committee votes to recommend a warning about gadolinium retention for gadolinium-based contrast agents when used d...
CDER director Janet Woodcock tells a House Energy and Commerce Health Subcommittee hearing that the current monograph system for over-the-counter drug...
The Consumer Healthcare Products Association says there is no need for FDA to approve a change for Imodium from over-the-counter to prescription statu...
Allergan transfers Restasis patents to a Native American tribe to shield them from review by the U.S. Patent Trial and Appeal Board.