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Latest US Food and Drug Administration Stories

2009-11-30 08:06:00

ROCKLAND, Mass., Nov. 30 /PRNewswire/ -- EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany, announced today that it received a refuse to file letter from the US Food and Drug Administration (FDA) on the New Drug Application (NDA) for Cladribine Tablets, EMD Serono's proprietary investigational oral formulation of cladribine, as a therapy for relapsing forms of multiple sclerosis (MS). "The company will work closely with the FDA to fully understand FDA's concerns and define a...

2009-11-24 15:01:00

SAN DIEGO, Nov. 24 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) announced today that the US Food and Drug Administration (FDA) has cleared for marketing Prodesse's ProParaflu+(TM) assay, a molecular test that detects and differentiates parainfluenza 1, 2 and 3 viruses, which cause lower respiratory tract infections. Prodesse is a wholly-owned subsidiary of Gen-Probe, a global leader in molecular diagnostics. "FDA clearance of our 510(k) application for ProParaflu+...

2009-10-29 06:00:00

SAN DIEGO, Oct. 29 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) today announced that the US Food and Drug Administration (FDA) has granted an EUA (emergency use authorization) for its test, the Prodesse ProFlu-ST(TM), to be used in CLIA high complexity laboratories for the diagnosis of 2009 H1N1 influenza virus infection, aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results, from a single sample in individuals who...

2009-10-15 06:00:00

PRINCETON, N.J., Oct. 15 /PRNewswire-FirstCall/ -- Soligenix, Inc., (Soligenix or the Company) (OTC Bulletin Board: SNGX), formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today that it has initiated enrollment in its confirmatory Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating orBec(®) for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD). The initiation of...

2009-10-06 05:00:00

IRVINE, Calif., Oct. 6 /PRNewswire/ -- A major increase in innovative concepts for exciting therapeutic and preventive new products in Australia has led to an expansion of GZP's activities Down Under, to better support clients in their efforts to take their programs to the US Food and Drug Administration. Our new office in downtown Brisbane, Australia was established on July 1 and we are adding Australia-based associates with FDA, TGA and EMEA experience to expand access to our...

2009-09-30 11:02:00

ROCKLAND, Mass., Sept. 30 /PRNewswire/ -- EMD Serono, Inc. an affiliate of Merck KGaA, Darmstadt, Germany, announced today the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Cladribine Tablets, EMD Serono's proprietary investigational oral formulation of cladribine, as a therapy for reducing relapses in people with relapsing forms of multiple sclerosis (MS). Cladribine Tablets has the potential to be the first orally administered...

2009-09-17 23:00:00

SAN DIEGO, Sept. 18, 2009 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported today positive, highly significant top-line results from the BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) trial. BLOSSOM confirms the results previously reported for the BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) trial and completes the lorcaserin Phase 3 pivotal registration program of 7,190 patients...

2009-09-16 08:00:00

TAMPA, Fla., Sept. 16 /PRNewswire/ -- Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has approved its New Drug Application for Zirgan(TM) (ganciclovir ophthalmic gel) 0.15% as a treatment for acute herpetic keratitis (dendritic ulcers). The FDA granted orphan drug designation to Zirgan for this indication in April 2007. (Logo: http://www.newscom.com/cgi-bin/prnh/20080220/CLW064LOGO )...

2009-08-28 09:42:00

Conference to Examine Latest in Healthcare Product Regulation, Trends, Technology ROCKVILLE, Md., Aug. 28 /PRNewswire-USNewswire/ -- Professionals concerned with developing and bringing safe and effective drugs, medical devices, biotechnology and other healthcare products to the worldwide market will convene in Philadelphia next month for the Regulatory Affairs Professionals Society's (RAPS) 2009 Annual Conference & Exhibition. Attendees will come from around the world for what is the...

2009-08-03 20:29:00

ANN ARBOR, Mich., Aug. 3 /PRNewswire/ -- Validation & Compliance Institute (VCI) is developing a series of training videos for the University of Michigan Medical Innovation Center (MIC). The videos will introduce University of Michigan researchers to the regulations that are required by the US Food and Drug Administration (FDA) in order to market medical devices. The training will help innovators to make decisions early in their projects that will save them time and money when they...


Word of the Day
tesla
  • The unit of magnetic flux density in the International System of Units, equal to the magnitude of the magnetic field vector necessary to produce a force of one newton on a charge of one coulomb moving perpendicular to the direction of the magnetic field vector with a velocity of one meter per second. It is equivalent to one weber per square meter.
This word is named for Nikola Tesla, the inventor, engineer, and futurist.