FDA

FDA Articles

As we have said before, updates from the FDA have the potential to make or break a company. In this case it seems like a mild setback, but further complications could prove to be catastrophic.
BioCryst Pharmaceuticals has received an update from the FDA. This approval is very welcome as BioCryst has been underperforming the market so far this year.
Shares of Pluristem Therapeutics saw a handy gain early Monday after the company said it had received a key update from the FDA.
Celgene received an update from the FDA early on Thursday. Although shares did not dip initially, this action could prove to be problematic for the biotech giant going forward.
Insmed has filed with the SEC for a secondary offering. This follows a surge in the share price following positive late-stage results from its clinical study in the treatment of nontuberculous...
Cellectis shares tumbled early on Tuesday after the firm announced that a couple of its early-stage studies were put on hold by the FDA.
BioCryst Pharmaceuticals saw its shares make a handy gain on early Tuesday after it released the final results from its mid-stage clinical trial in hereditary angioedema.
SteadyMed shares plummeted after the firm had a setback from the FDA regarding its pulmonary arterial hypertension treatment.
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) shares remained relatively muted on Monday after the firm announced a key U.S. Food and Drug Administration (FDA) approval for its gout treatment...
Valeant Pharmaceuticals International, Inc. (NYSE: VRX) saw its shares make a handy gain on Thursday after the company provided an update from the U.S. Food and Drug Administration (FDA)....
Here are four biotech stocks for which the team of analysts at Jefferies, and analysts at other firms, see big upside potential from upcoming near-term drug study catalysts.
A blockbuster drug is about to get a chance to have even higher sales, as the FDA has expanded its approval of Imbruvica for the treatment of adult patients with chronic graft versus host disease.
Gilead Sciences, Inc. (NASDAQ: GILD) shares basically remained unchanged after the firm announced an approval from the U.S. Food and Drug Administration (FDA). Essentially, the FDA approved Vosevi...
Puma Biotechnology, Inc. (NASDAQ: PBYI) saw its shares touch a multiyear high on Tuesday after the firm reported a key approval by the U.S. Food and Drug Administration (FDA). Specifically, the...
Ocular Therapeutix shares were absolutely crushed on Wednesday after the company received less than favorable news from the FDA regarding its Dextenza in the treatment of ocular pain following...