US Stock Movers On FDA Decision (SNTA, MYL, YMI, CADX, HGSI)
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Mylan Inc. (NASDAQ: MYL) today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Didanosine Delayed-release Capsules, 125 mg, 200 mg, 250 mg and 400 mg, the generic version of Bristol Myers Squibb's HIV treatment Videx® EC.
YM BioSciences Inc. (AMEX: YMI), announced the pre-publication of pivotal preclinical data for CYT387, the company's highly selective and potent JAK1/2 inhibitor, currently in a Phase I/II trial for myelofibrosis.
Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced today that, based on feedback received during a meeting with the U.S. FDA on April 16, 2010, it plans to re-submit a New Drug Application (NDA) for its investigational product candidate, OFIRMEV™ (acetaminophen) injection, within the next 30 days.
Human Genome Sciences, Inc. (NASDAQ: HGSI) today announced that Novartis (NYSE: NVS) has withdrawn a Marketing Authorization Application(MAA) to the European Medicines Agency (EMA) for approval to market JOULFERON (albinterferon alfa-2b, known in the United States as ZALBIN) for the treatment of chronic hepatitis C.
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