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Latest US Food and Drug Administration Stories

2010-04-14 08:55:00

Primary Endpoint achieved as required for United States Food and Drug Administration (FDA) submission BEDMINSTER, N.J. and SYDNEY, April 14 /PRNewswire-FirstCall/ -- QRxPharma (ASX: QRX and OTCQX: QRXPY) announced today the successful completion of the first of two pivotal Phase 3 studies for MoxDuo(®)IR, an immediate-release Dual-Opioid(TM) pain therapy. Required for FDA New Drug Application (NDA) submission, this combination rule study -- comparing the efficacy and...

2010-04-13 07:00:00

DEARBORN, Mich., April 13 /PRNewswire/ -- SIMCO Electronics has chosen Validation & Compliance Institute (VCI) to provide online training for its employees who provide instrument calibration to the biotech, pharma and medical devices industries. SIMCO wanted to transition from conventional training to interactive online training to assure current Good Manufacturing Practices (cGMP) are used by all their employees. SIMCO needed to make sure that its employees stayed current on the...

2010-03-30 08:55:00

Pilot Study to Evaluate Pharmacokinetic Profile of Experimental Formulations BEDMINSTER, N.J. and SYDNEY, March 30 /PRNewswire-USNewswire/ -- QRxPharma (ASX: QRX and OTCQX: QRXPY) announced today initiation of the Company's first Phase 1 trial to evaluate the pharmacokinetic (PK) profiles of experimental controlled-release (CR) morphine and oxycodone formulations that will be incorporated into MoxDuo®CR. MoxDuo®CR contains a fixed 3:2...

2010-03-18 08:00:00

WASHINGTON, March 18 /PRNewswire/ -- Ahead of World TB Day, US Food and Drug Administration Commissioner Margaret Hamburg helped public and private sector partners launch a new collaboration to significantly accelerate the development of combination treatments for tuberculosis -- and replace an almost 50-year-old drug regimen. Created by the Global Alliance for TB Drug Development, the Critical Path Institute, and the Bill & Melinda Gates Foundation, the initiative could potentially...

2010-03-12 06:30:00

SAN DIEGO, March 12, 2010 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today reported financial results for the fourth quarter and full year ended December 31, 2009. Arena reported a lower net loss allocable to common stockholders in the fourth quarter of 2009 of $29.8 million, or $0.32 per share, compared to a net loss allocable to common stockholders in the fourth quarter of 2008 of $62.5 million, or $0.84 per share, and a net loss allocable to common...

2010-02-26 07:00:00

SAN DIEGO, Feb. 26, 2010 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today that the US Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) date of October 22, 2010, for the review of the lorcaserin New Drug Application (NDA). The acceptance of the lorcaserin NDA filing confirms that the application is sufficiently complete to permit a substantive review, and the PDUFA date is the goal date for the FDA to complete its...

2010-02-24 07:00:00

SAN DIEGO, Feb. 24, 2010 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today that its New Drug Application (NDA) for lorcaserin, Arena's internally discovered and developed drug candidate for weight management, including weight loss and maintenance of weight loss, has been accepted for filing by the US Food and Drug Administration (FDA). Arena submitted the lorcaserin NDA on December 22, 2009, and expects to learn the Prescription Drug User Fee Act (PDUFA)...

2010-02-23 07:30:00

BEDFORD, Mass., Feb. 23 /PRNewswire/ -- Instrumentation Laboratory (IL) today announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its HemosIL D-Dimer HS 500 assay. Additionally, the Company received a license from Health Canada for the product. The Company will now initiate commercialization of HemosIL D-Dimer HS 500 in North America, with their distribution partner, Beckman Coulter, Inc. In April 2009, the assay was previously released in...

2010-02-18 16:54:00

RESEARCH TRIANGLE PARK, N.C., Feb. 18 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) is reviewing label changes proposed today by the US Food and Drug Administration (FDA) for asthma medications containing long-acting beta-agonists (LABAs), such as GSK's Advair (salmeterol / fluticasone propionate). GSK and makers of the other affected medicines containing LABAs have 30 days to agree with the proposed changes or state why they are not warranted. "We will work with FDA to ensure...

2010-01-28 08:00:00

CARLSBAD, Calif., Jan. 28 /PRNewswire/ -- Aubrey Inc., an advanced wound care company, announced it has received clearance from the US Food and Drug Administration (FDA) to market the AWBAT Plus product line in the United States. This represents a significant milestone for the company as it is the second product line to be launched in the company's two year history. The initial product line, AWBAT, continues to gain adoption in burn centers throughout the US and is planned for launch in...


Word of the Day
barratry
  • The offense of persistently instigating lawsuits, typically groundless ones.
  • An unlawful breach of duty on the part of a ship's master or crew resulting in injury to the ship's owner.
  • Sale or purchase of positions in church or state.
This word ultimately comes from the Old French word 'barater,' to cheat.
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