WASHINGTON Federal health regulators say an experimental insomnia drug from Merck can help patients fall asleep, but it also carries worrisome side effects, including daytime drowsiness and suicidal thinking. The Food and Drug Administration ... Washington Post, 2 hours ago
FDA has safety concerns on Merck insomnia drug - Denver Post, 2 hours ago
FDA staff say Merck's sleep drug effective, question dose levels - Reuters, 5 hours ago
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Image: Plan B One-Step (Photo courtesy of Teva Pharmaceuticals). The US Food and Drug Administration (FDA; Silver spring, MD, USA) has approved the sale of the emergency oral contraceptive Plan B One-Step without a prescription to girls aged 15 ...Hospi Medica, 2 hours ago FDA approves Plan B for girls as young as 15 Reuters, 2 weeks ago
2:36pm BST May 20 (Reuters) - Peregrine Pharmaceuticals said it reached an agreement with the U.S. Food and Drug Administration on the design of a late-stage trial for its experimental lung cancer drug. The late-stage trial will compare a ...Reuters UK, 4 hours ago Peregrine Pharma Enters Into Deal With FDA On Bavituximab Phase III Trial Design RTTNews.com, 4 hours ago Peregrine Pharmaceuticals Reaches Agreement With FDA on a Phase III Trial Design for Bavituximab in Second-Line Non-Small Cell Lung Cancer BusinessWeek, 4 hours ago Peregrine Pharmaceuticals (PPHM) and the FDA agree on a Phase III trial design for Bavituximab. "We will now focus on starting the Phase III trial while continuing ongoing partnering discussions," says CEO Steven King. Shares halted. (PR) Seeking Alpha, 4 hours ago
Cubist Pharmaceuticals, Inc., a biopharmaceutical company, has received fast track status from the FDA for the company's late-stage antibiotic candidate ceftolozane/tazobactam in the previously granted Qualified Infectious Disease Product, or QIDP, ...Individual.com, 3 hours ago FDA Grants Premarket Approval PMA For The SEDASYS System For Healthy Patients Undergoing Sedation During Routine Colonoscopy And EGD Procedures Pharmacy Choice, 7 hours ago US FDA approves Janssen Biotech 's Simponi for treatment of ulcerative colitis PharmaBiz, 3 days ago FDA approves J&J's Simponi to treat ulcerative colitis Reuters, 4 days ago
Jiangsu Hengrui Medicine Co., Ltd. (SHSE: 600276) revealed that a notice has been received from the Food and Drug Administration (FDA) saying that letrozole tablet produced by the company has gotten certification from the government agency and ...Individual.com, 5 hours ago Sequester Withholding of FDA User Fees Irks Industry Roll Call Online, 2 days ago FDA Urges Hospitals to Check Mattresses Hospi Medica, 4 days ago FDA allows continued sale of generic Opana painkiller Inside Counsel, 4 days ago
More from: India Infoline, DNA...and 8 other sources
Thoratec Corporation, a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, has received the US Food and Drug Administration (FDA) approval to market the HeartMate II Pocket Controller, ...PharmaBiz, 12 hours ago Thoratec Gets FDA Nod To Sell HeartMate II Pocket Controller RTTNews.com, 3 days ago FDA Approves Thoratec's HeartMate II Pocket Controller QMED, 2 days ago Thoratec wins FDA nod for HeartMate controller FiercePharma, 2 days ago
According to the National Cancer Institute, an estimated 238,590 men will be diagnosed with prostate cancer and 29,720 will die from the disease in 2013. Credits: Yahoo Images Holistic Health newsletter E-mail * do not change Contact Email Contact ...Examiner.com, 2 hours ago FDA Approves Oramed Pharmaceuticals, Inc. (NASDAQ:ORMP)?s Flagship Drug Plans ? ORMP, GILD, MNKD, CLSN, ONTY Galaxy Stocks, 3 hours ago FDA approves GSK's Breo Ellipta to treat COPD Center Watch, 2 days ago Oramed Pharma (ORMP) OK'd by FDA for ORMD-0801 IND Street Insider, 3 days ago
|Bio Spectrum Asia, 8 hours ago|
US FDA issues draft guideline on expanded access to IND for treatment; expects industry views before July 1
The US Food and Drug Administration (FDA) has now issued a draft guideline on expanded access to investigational new drugs (IND) for treatment use in a 21 questions and answers format. The regulatory authority is now seeking the responses on this by ...PharmaBiz, 15 hours ago FDA's tobacco head plans to move quickly on industry issues [Richmond Times-Dispatch, Va.] BusinessWeek, 3 days ago
The advisory panel to the US Food & Drug Administration (FDA) will meet in mid-July 2013 to review QRxPharma's resubmitted application for its painkiller MoxDuo. In July 2012, the FDA refused to accept the drug on the grounds that it combined two ...Individual.com, 23 hours ago QRxPharma to face FDA panel in July Australian Financial Review, 3 days ago FDA reviewing robot complaints New York Business Journal, 2 days ago FDA Panel to Review New Avandia Results Med India, 1 month ago
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