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About 1244 results for "fda"

CBS Health: FDA may tighten restrictions on testosterone drugs

Federal health experts said Wednesday there is little evidence that testosterone-boosting drugs are effective for treating common signs of aging in men and that their use should be narrowed to exclude millions of Americans currently taking them. ... CBS News, 47 minutes ago

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FDA clears Siemens CT scanner

The FDA approves Siemens Healthcare's lower-priced Somatom Scope CT scanner. The 16-slice scanner is designed use in private radiology practices, community hospitals and other specialty practices by virtue of its light weight and low (130.2 sq. ft.) ...
 Seeking Alpha5 hours ago FDA Clears Siemens SOMATOM Scope CT System  4 Traders5 hours ago FDA Clears Siemens' SOMATOM Scope CT System  TMC Net1 hour ago

Faster-acting erectile dysfunction drug gets FDA approval

Sept 18 (Reuters) - An erectile dysfunction drug that reduces by half the time patients need to take the pill before sexual activity has been approved by the U.S. Food and Drug Administration. Developed by Auxilium Pharmaceuticals Inc and Vivus ...
 CNBC8 hours ago FDA approves Vivus' ED treatment  Minyanville2 hours ago FDA Approves New Fast-Acting Erectile Dysfunction Drug  RTTNews.com1 hour ago UPDATE 1-Faster-acting erectile dysfunction drug gets FDA approval  Reuters UK2 hours ago

FDA OKs faster-acting label for ED drug Stendra

Federal regulators have approved a new label for Vivus' impotence drug, stating that it becomes effective in half the time that the previous label had stated. Shares jumped more than 9 percent before the opening bell Thursday. The label on ...
 CNBC7 hours ago FDA approves new label for impotence drug Stendra stating that it starts working in 15 minutes  INO.com7 hours ago FDA OKs Faster-Acting Label for Stendra  PharmaceuticalProcessing6 hours ago

FDA advisers shoot down Clarus' pitch for a new low-T drug

Amid widespread safety concerns surrounding testosterone drugs, an FDA panel has recommended against Clarus Therapeutics' oral treatment, dimming the future for the company's sole product. In a joint meeting of the FDA's urologic and drug safety ...
 FierceBiotech44 minutes ago Clarus Therapeutics Reports FDA Advisory Committees Vote on REXTORO(TM) for Low Testosterone in Men  Fat Pitch Financials1 hour ago

Salix Announces FDA User Fee Goal Date of February 28, 2015 for XIFAXAN® 550mg sNDA for Treatment of Irritable Bowel Syndrome with Diarrhea

. (NASDAQ:SLXP) today announced that the Food and Drug Administration (FDA) considers the Company's August 29, 2014 resubmission of its supplemental New Drug Application (sNDA) for XIFAXAN® We believe the efficacy and safety data collected in ...
 Wall Street Select2 hours ago

09.18.14 -- FDA News Roundup: Astellas, Sanofi Pasteur, Orexigen, And More

» Inspection WHITE PAPER: Deconstructing The Blue Dye Leak Test Method By Oliver Stauffer, PTI Packaging and Inspection Systems Blister package manufacturing for tablets and capsules has process and material parameters that ...
 Pharmaceutical Online1 hour ago

FDA Proposes New Study To Test Device Labeling Standardization

By The FDA is taking steps to further study the feasibility of standardizing device labeling using new formats currently under development. A recent Federal Register notice says that the agency is planning to compare the labeling of six ...
 Medical Design Online1 hour ago FDA takes step toward standardized medical device labeling  FierceMedicalDevices1 day ago

FDA Advisory Panel Urges Restrictions on Testosterone Use

A combined US Food and Drug Administration (FDA) advisory panel has voted nearly unanimously to change the labeling for testosterone-replacement products, with the aim of tamping down on their current widespread use for "age-related" ...
 General Medicine eJournal4 hours ago FDA Panels Examine Testosterone Treatment  Roll Call Online5 hours ago FDA panel backs limiting use of testosterone replacement drugs  Yahoo! Finance22 hours ago Put a lid on 'Low-T' drug use, FDA panel advises, threatening AbbVie, Lilly meds  FiercePharma3 hours ago

FDA's call on Rytary delayed by 3 months

 Bio Spectrum Asia7 hours ago FDA Delays Decision On IMPAX Laboratories, Inc. Parkinson's Drug RYTARY  BioSpace5 hours ago Impax Pharma: FDA Extends PDUFA Date For Review Of RYTARY NDA  RTTNews.com1 day ago Impax Pharmaceuticals Announces Extension of RYTARY FDA Review Date to January 9, 2015  ADVFN India1 day ago
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