The FDA approved Sephience - PTC's oral therapy for a rare metabolic disorder called phenylketonuria - last month, potentially countering revenue declines due to regulatory scrutiny and competition from cheaper rivals for its top-selling muscular disorder therapies, Translarna and Emflaza.

A series of panels convened by the Food and Drug Administration is raising concerns that the agency is skirting federal rules and promoting fringe views about antidepressants and other products

After a more than decadelong process to bring the experimental drug elamipretide to market, the treatment’s approval has repeatedly hit roadblocks.

Some imported cookware made with certain materials may leach "significant levels" of lead into food, which can cause serious health effects, the FDA said.