FDA

Analysts at Citi turned bullish on Novavax, Inc. (NASDAQ: NVAX), a small-cap clinical-stage vaccine company. The firm's Joel Beatty upgrades Novavax's stock rating from Neutral to Buy with a price target boosted from $1.10 to $1.60. Novavax's phase 1 and phase 2 data for its flu vaccine called...

Shares of Exelixis, Inc. (NASDAQ: EXEL) were trading higher by 20 percent early Monday morning after the company announced an encouraging update for its CABOMETYX (cabozantinib) therapy for the treatment of patients with advanced hepatocellular carcinoma. The U.S. Food and Drug Administration has...

The U.S. Food and Drug Administration's approval of Mylan N.V. (NASDAQ: MYL)'s generic version of Copaxone for the treatment of relapsing multiple sclerosis should be seen as a "clear negative" for Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA)'s Glatopa franchise, analysts at Baird said. The firm's...

Shares of PTC Therapeutics, Inc. (NASDAQ: PTCT) gained more than 13 percent Friday after the FDA found that the company's experimental drug to treat Duchenne muscular dystrophy may work. The FDA's Advisory Committee meeting ruled that the body of evidence for the company's ataluren...

Despite a more than 35 percent plunge in DexCom, Inc. (NASDAQ: DXCM)'s stock, analysts at Canaccord Genuity continue to hold a bullish outlook. The firm's Kyle Rose maintains a Buy on DexCom's stock with a price target lowered from $90 to $69. DexCom's stock was hard hit on Thursday...

After striking a 10-year high in June, Altria Group Inc (NYSE: MO) saw a 16-percent pullback driven largely by the Food and Drug Administration’s call to reduce cigarette nicotine. Cowen Equity Research had initially reacted to the news with a $60 price target and Hold rating, but now, amid...

The U.S. Food and Drug Administration sent a letter to doctors highlighting potential negative side effects from Intercept Pharmaceuticals Inc (NASDAQ: ICPT)'s liver disease medicine called Ocaliva. The FDA said in its letter that if it is incorrectly dosed in patients with moderate to severe...

As the vacation season ends with rumbles of war, hints of impeachment, the afterglow of a solar eclipse and the ongoing nightmare of a natural disaster, it’s time to step back and look at the surreal summer of 2017. To paraphrase Stephen Stills: Stop, hey, what’s that sound? Everybody...

It’s been a rough summer for the tobacco industry. After the U.S. Food and Drug Administration announced plans to limit nicotine intake, the New York City Council voted Thursday to raise the price of cigarettes, halve the number of licensed retailers and, in a move causing more widespread...

The U.S. Food and Drug Administration's policy shift on tobacco and nicotine regulation initially resulted in a 20-percent plunge in Altria Group Inc (NYSE: MO), the parent company of notable cigarette brands including Philip Morris. Needless to say, the FDA's crackdown on nicotine products is a...

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...