And Cobenfy's approval comes after two other recent setbacks in the late-stage schizophrenia pipeline; namely, the FDA’s rejection of Minerva Neurosciences’ application for roluperidone and ...

The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.

A top official at the Food and Drug Administration recently overruled government scientists on the availability of two ...

The Food and Drug Administration yesterday released a safety notice announcing a software patch is available to address ...

Managed Healthcare Executive gives C-suite executives in health plans and provider organizations news and strategies for value-driven solutions.

The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use ...

Merck (MRK) stock in focus as its lung disease drug Winrevair gains FDA priority review for a label update based on Phase 3 ...

Sky-high sales prospects for Bristol Myers Squibb's new schizophrenia treatment Cobenfy may have to be scaled down after a trial designed to expand the label of the recently approved drug failed ...

FDA officials issued the import alerts Tuesday to prevent 58 models of Olympus devices used in urinary, respiratory, abdominal and pelvic procedures from reaching customers in the U.S.