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Last updated on April 19, 2014 at 18:42 EDT

Latest FDA Stories

2014-04-09 08:30:08

SAN DIEGO, April 9, 2014 /PRNewswire/ -- Aethlon Medical, Inc. (OTCQB: AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce. http://photos.prnewswire.com/prnvar/20090325/LA88762LOGO-b In the coming months, we plan to initiate the first FDA approved study of Hemopurifier® therapy in the United States. Historically, U.S. clinical progression of extracorporeal devices directed toward a single disease indication has been a proven model for value...

2014-04-09 08:29:28

Secures Intellectual Property Rights SEATTLE, April 9, 2014 /PRNewswire/ -- Oricula Therapeutics, LLC, a biotech company uniquely positioned to introduce medications to preserve hearing, announced that it has secured initial funding and licensed intellectual property from University of Washington. These represent key steps toward achieving the company's vision to commercialize compounds it has developed to prevent certain types of hearing loss. The company's product will be the...

US Honey Producers Concerned About Sweetened Substitutes
2014-04-09 07:17:19

Lawrence LeBlond for redOrbit.com - Your Universe Online Honey is an important food staple, with more than 400 million pounds being consumed annually in the US. However, less than half of this amount – 149 million pounds – actually came from honey produced in the United States last year, according to USDA data. Now, the FDA is dipping its hand into the pot, drafting new guidance on what honey is and how it should be labeled. Under the guidance, the food regulator maintains that food...

2014-04-08 23:31:30

On March 28, the US FDA announced that all Alli weight loss products are voluntarily recalled by GlaxoSmithKline because the company believes that some packages were tampered. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) April 08, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on safety alerts for...

2014-04-08 23:29:08

Strategic relationship between quantitative imaging leader and key teleradiology company provides Physicians and Hospitals with comprehensive volumetric MRI reports. San Diego, CA (PRWEB) April 08, 2014 CorTechs Labs, Inc. is pleased to announce a partnership agreement with StatRad, LLC, a leading provider of innovative teleradiology services, which will distribute NeuroQuant® to its hospital and clinic clients. RadConnect, a division of StatRad that provides a medical image sharing...

2014-04-08 23:01:27

Forum to Focus On FDA Requirements, Potential Hurdles and Tips for Developing Therapeutic Products Derived from Human Stem Cells Washington (PRWEB) April 08, 2014 DIA will host a forum called “FDA Regulation of Therapeutic Products Derived From Human Stem Cells: Successfully Navigating the Regulatory Hurdles” during the DIA 2014 50th Annual Meeting at the San Diego Convention Center from June 15 to 19. The Food and Drug Administration (FDA) regulates many therapeutic products derived...

2014-04-08 16:23:30

CASTLE ROCK, Colo., April 8, 2014 /PRNewswire/ -- Venaxis, Inc. (NASDAQ:APPY), an in vitro diagnostic company focused on obtaining FDA clearance for and commercializing its CE Marked APPY1(TM) Test, a rapid, multiple biomarker-based index assay for identifying patients that are at low risk for appendicitis, today announced the closing of its previously announced underwritten public offering of 8,335,000 shares of its common stock at a price to the public of $2.40 per share. In...

2014-04-08 12:32:36

Miami e-cigarette small business is the first to back potential rule. MIAMI, April 8, 2014 /PRNewswire-iReach/ -- SoundVape, a luxury e-cigarette brand based in Miami, announced today that it will advocate for the regulation of e-cigarette products by the U.S. Food and Drug Administration. (Photo: http://photos.prnewswire.com/prnh/20140408/MN00099) The announcement comes less than a week after FDA Commissioner Margaret Hamburg announced that the FDA is pushing hard to release a...

2014-04-08 12:31:49

Three pivotal trials showed PRADAXA as non-inferior to warfarin in reduction of DVT and PE recurrence; fourth pivotal trial showed PRADAXA reduced risk of recurrence by 92 percent compared to placebo RIDGEFIELD, Conn., April 8, 2014 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Pradaxa(®) (dabigatran etexilate mesylate) for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in...

2014-04-08 08:33:01

The auto-injector is designed to allow quick administration when drug overdose first occurs LOS ANGELES, April 8, 2014 /PRNewswire/ -- Family members and caregivers of individuals with opiate drug addiction problems heaved a sigh of relief earlier this month when the FDA announced it was issuing fast-track approval to Evzio (naloxone hydrochloride), an injectable medication that can be administered to someone who is known or suspected to have had an overdose of opioid drugs. The drug...