FDA Approves Exalgo™ Extended-Release TabletsCombinatoRx, Incorporated (NASDAQ: CRXX) announced that the U.S. Food and Drug Administration (
FDA) has approved the New Drug Application (NDA) for Exalgo™ (hydromorphone HCl) extended-release tablets, for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time...
Source: mnt.toExactech Platform Fracture Stem For Shoulder Surgeries Receives FDA ClearanceExactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, announced that the company has received 510(k) clearance from the U.S. Food and Drug Administration (
FDA) to market the company's Equinoxe® Platform Fracture Stem, the latest addition to the company's shoulder arthroplasty line...
Source: mnt.toNew Data From Caldolor(R) Study In Burn Patients To Be Presented At 42nd Annual Meeting Of The American Burn AssociationCumberland Pharmaceuticals Inc. (Nasdaq: CPIX) announced that data from a recent study evaluating the safety and efficacy of Caldolor® (ibuprofen) Injection in treating pain and fever in hospitalized burn patients will be presented at the 42nd Annual Meeting of the American Burn Association in Boston...
Source: mnt.toAdvanced Cell Technology's RPE Cells Granted Orphan Drug Status From FDA For Treatment Of Stargardt's Macular DystrophyAdvanced Cell Technology, Inc. (OTCBB: ACTC), a biotechnology company applying cellular technology in the field of regenerative medicine, announced today that the U.S. Food and Drug Administration (
FDA) has granted orphan drug designation for the company's MA09-hRPE cells for use in the treatment of Stargardt's Macular Dystrophy (SMD)...
Source: mnt.toPharmaceutical Industry Support Not Desirable But Frequently Accepted By Residency Program DirectorsMost directors of internal medicine residency training programs would prefer not to accept pharmaceutical support for the residencies they oversee, but more than half report doing so, according to an article in the February 22 issue of Archives of Internal Medicine, one of the JAMA/Archives journals...
Source: mnt.toSunridge Receives Approval For Its Non-Invasive Glaucoma Treatment In ChinaSunridge International (OTC Bulletin Board: SNDZ), announced that China's State Food and Drug Administration, (SFDA), had approved the firm's Pneumatic Trabeculoplasty (PNT) treatment in China. In making the announcement today, Sunridge International's CEO, G...
Source: mnt.toVivus's Qnexa Will Become Decision Resources' Clinical Gold Standard In 2013 For The Treatment Of ObesityDecision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, for the treatment of obesity, Vivus's Qnexa (the phentermine/topiramate combination) will earn Decision Resources' proprietary clinical gold standard in 2013 and through 2018 following its anticipated U.S. approval for the disease in 2011...
Source: mnt.toThree Harvard School Of Public Health Alumni Named To New FDA Tobacco Advisory CommitteeThe recently formed Food and Drug Administration (
FDA)'s Center for Tobacco Products has just created a new Tobacco Products Scientific Advisory Committee to review and evaluate safety, dependence, and health issues relating to tobacco products and provide appropriate advice, information, and recommendations to the Commissioner of Food and Drugs...
Source: mnt.toRexahn Pharmaceuticals Submits Zoraxel Phase IIb Protocol To FDARexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, announced that it has submitted a Phase IIb protocol to the
FDA for ZoraxelTM for the treatment of erectile dysfunction (ED). "The progression of Zoraxel's clinical program is very encouraging," said Rexahn Chief Executive Officer, Dr...
Source: mnt.to
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