After a long run of regulatory stumbles and the recent wit | "Following the withdrawal of Ocaliva from the U.S. market, we ...

It was early November. The Food and Drug Administration had just endured the high-profile, dramatic exit of its top drug regulator. Personnel complaints had racked up. And other grievances within the ...

Collaborative discussions” with the FDA encouraged Praxis to submit early next year an approval filing for its epilepsy drug. Elsewhere, Rezolute shares plunged and Centessa announced a new CEO.

Aldeyra submitted the single successful trial to the FDA over the summer and the agency accepted the resubmitted NDA for ...

These food safety concerns could snowball into disease outbreaks, pandemics, and rising food prices. Secretary of the U.S. Department of Health and Human Services, Robert F. Kennedy Jr., has made his ...

The head of the Food and Drug Administration’s drug center abruptly resigned Sunday after federal officials began reviewing “serious concerns about his personal conduct,” according to a government ...