The FDA will submit a boxed warning and other labeling limits for Elevidys, an adeno-associated virus and vector-based gene ...

The Food and Drug Administration (FDA) defied the advice of its own drug safety experts to warn pregnant women about Tylenol for nearly a decade, internal reports and presentations obtained by the ...

The US Food and Drug Administration is rolling out a new program to speed up drug reviews by emphasizing clearer, more frequent communication with companies, aided by a surge of new hires.

The U.S. Food and Drug Administration said on Wednesday that it has launched a pilot program to give drugmakers faster ...