FDA

Cigarette manufacturers plummeted Friday on news that the U.S. Food and Drug Administration would take steps to limit cigarette nicotine to non-addictive levels. “The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes – the only legal...

Under a new deal between the U.S. Food and Drug Administration and the medtech device industry, manufacturers would be required to report device defects within three months of detecting their potential threat of injury ━ a tripling of the current 30-day reporting period. Events requiring recall or...

Shares of Amicus Therapeutics, Inc. (NASDAQ: FOLD) soared higher by more than 25 percent on Tuesday in reaction to the company's announcement that there is now a clear path to approval for its migalastat NDA therapy. Amicus suffered a major setback for its therapy in November, 2016 when the U.S....

Senate Minority Leader Charles Schumer wants federal authorities to investigate a hot new trend in nose candy: “Snortable chocolate” powder laced with caffeine that reportedly gives the user a sweet buzz. The New York Democrat is targeting such products as “Coco Loko,” which...

Shares of Endo International plc - Ordinary Shares (NASDAQ: ENDP) were trading lower by more than 10 percent Friday morning in reaction to the U.S. Food and Drug Administration's request for the company to withdraw from the market its opioid painkiller called Opana ER. Stifel's Annabel Samimy felt...

Sarepta Therapeutics Inc (NASDAQ: SRPT), a smid-cap biopharmaceutical company that focuses on the treatment of rare neuromuscular diseases including Duchenne muscular dystrophy, saw its stock peak north of $60 per share in late 2016 after the U.S. Food and Drug Administration green-lighted its DMD...