FDA

La Jolla Pharmaceutical Company (NASDAQ: LJPC) has an upcoming catalyst in the form of a Feb. 28 PDUFA date. An analyst at H.C. Wainwright recommends buying of the shares ahead of the decision.  The Analyst H.C. Wainwright analyst Edward White initiated coverage of the shares of La Jolla...

Omeros Corporation (NASDAQ: OMER) shares are trading higher Tuesday after the commercial-stage biopharma company announced FDA approval for its supplemental new drug application, or sNDA, for OMIDRIA, which expands the indication to include use in pediatric patients, from birth through 17 years...

After Heron Therapeutics Inc (NASDAQ: HRTX), Bristol-Myers Squibb Co (NYSE: BMY) and Dynavax Technologies Corporation (NASDAQ: DVAX) found favor with the FDA, it's Ultragenyx Pharmaceutical Inc (NASDAQ: RARE)'s turn, as the rare disease therapy company seeks FDA approval for its...

Dynavax Technologies Corporation (NASDAQ: DVAX), a clinical-stage immunotherapy company, confirmed on Thursday the U.S. Food and Drug Administration approved its two-dose vaccine  The company failed to gain approval for its therapy in February 2013 and in November 2016. But now that the...

Adamas Pharmaceuticals Inc (NASDAQ: ADMS), a small-cap pharmaceutical company that develops therapies to treat chronic neurologic disorders, is a "misunderstood" stock that has a potential upside of four times, Kerrisdale Capital said in a new report. Adamas is expected to soon launch its first...

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...