FDA
FDA Articles
Insmed shares screamed higher on Wednesday. The driver was an SEC filing stating the FDA had granted Arikace breakthrough therapy designation.
Published:
MannKind is just about a month away from the FDA decision on Afrezza as the first inhalable insulin treatment for diabetes. Afrezza almost certainly will become a blockbuster drug if approved.
Published:
ThinkstockVIVUS Inc. (NASDAQ: VVUS) investors have a lot to be disappointed about these days. America’s ballooning waistline is reaching a critical level, yet VIVUS did not even manage to close up...
Published:
In a new report, the analysts at health care boutique Leerink highlight numerous upcoming catalysts for some top stocks in the sector. Catalysts may move the stocks sharply either way, depending on...
Published:
GW Pharmaceuticals was one of the stocks surging on Friday, on news that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation status to the company's Epidiolex.
Published:
Halozyme Therapeutics saw its stock surge on Thursday on news reports that the FDA has removed its clinical hold on patient enrollment and dosing of in the certain ongoing Phase 2 trials.
Published:
ThinkstockThe Food & Drug Administration has just put another dark cloud over the business of tanning booths. This FDA issue is a final order which reclassifies sunlamp products and ultraviolet...
Published:
courtesy of philip morris internationalThe U.S. Food & Drug Administration (FDA) has come out and proposed to extend its tobacco authority to additional tobacco products, including e-cigarettes....
Published:
24/7 Wall St. wanted to evaluate the prospects for several would-be blockbuster drugs. Some of these have approvals already in hand, while others have pending FDA approval verdicts.
Published:
In a new research report, the Healthcare team at UBS took an in-depth look at the top companies that are making major advances in cancer therapeutics. Here is the UBS list of stocks that are rated...
Published:
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...
Published:
Last Updated:
While the FDA has been far from a friend to MannKind over the past few years, the latest FDA panel backing may have given diabetes patients and investors some hope. That hope was diminished Monday...
Published:
MannKind has a serious victory within its grasp. The company has struggled to get its Afrezza inhalable insulin to market for years, and that dream now seems to be within its grasp.
Published:
ThinkstockMannKind Corp. (NASDAQ: MNKD)had been trading as though the stock was bracing for an U.S. Food and Drug Administration (FDA) panel decision recommending against the approval of its...
Published:
Zogenix has traded like a company that is about to implode. Its highly controversial Zohydro has been getting inquiries into how it was approved for marketing despite an FDA panel being against the...
Published: