U.S. Food and Drug Administration

The biggest bit of marijuana industry news in the week ending August 12 was that the DEA rejected a call to loosen federal restrictions on marijuana.
Jon C. Ogg
AcelRx Pharmaceuticals announced an update on the timing and potential content of its resubmission of the New Drug Application (NDA) for Zalviso.
Chris Lange
Source: ThinkstockOncolytics Biotech Inc. (NASDAQ: ONCY) announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation for Reolysin. Reolysin is the company’s lead...
Chris Lange
GW Pharmaceuticals reported top-line results from the first of three Phase 3 trials for Sativex.
Chris Lange
Analysts are beginning to make their calls for what the future will hold for Gilead Sciences, AbbVie and Express Scripts.
Chris Lange
AbbVie and Express Scripts have entered into an exclusive agreement under which Express Scripts will distribute AbbVie's hepatitis treatment.
Chris Lange
Array BioPharma has announced that it had reached a definitive agreement with Novartis to regain full worldwide rights to cancer drug binimetinib.
Chris Lange
Avanir Pharmaceuticals announced that it has entered into a definitive agreement with Otsuka Pharmaceutical for a $17.00 per share buyout.
Chris Lange
Source: U.S. Food & Drug AdministrationA purported herbal sexual health supplement called O.M.G. has been found by the U.S. Food and Drug Administration (FDA) to contain generic sildenafil, the...
Paul Ausick
After markets closed last Friday, MannKind announced that the FDA had approved Afrezza, a rapid-acting, inhaled insulin powder that improves glycemic control in adults with diabetes.
Paul Ausick
Source: ThinkstockThe U.S. Food and Drug Administration (FDA) late Friday afternoon announced that it has approved Afrezza, a rapid-acting, inhaled insulin power that improves glycemic control in...
Paul Ausick
Shares of Sarepta Therapeutics went through the roof Monday morning following an announcement that it plans to have a New Drug Application filed with the FDA by the end of 2014 for its muscular...
Paul Ausick
Usually when you see stocks double, it is based on a buyout or a major partnership development. That is not the case for Furiex Pharmaceuticals, which soared on news of positive top-line study...
Jon C. Ogg
Chelsea Therapeutics International is on the leader board for percentage gains on Thursday, with a rise of 111% or so. And it isn't even on news of a buyout. Can the company live up to its potential?
Jon C. Ogg
Source: ThinkstockAny time investors look for companies growing sales the most, one area that almost always stands out is the up and coming biotech stocks. After all, sales can grow from close to...
Jon C. Ogg