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Latest US Food and Drug Administration Stories

2010-06-02 07:00:00

SAN DIEGO, June 2, 2010 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today that the US Food and Drug Administration (FDA) has notified the company of the tentative scheduling of an Endocrinologic and Metabolic Drugs Advisory Committee meeting on September 16, 2010, for the review of the lorcaserin New Drug Application (NDA). Lorcaserin is Arena's internally discovered and developed drug candidate for weight management, including weight loss and maintenance...

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2010-05-12 06:15:00

The US Food and Drug Administration (FDA) plans to look into US pharmacy chain Walgreens after the company announced it will start selling genetic testing kits to help people asses their risk of inherited diseases. Walgreens said Tuesday it plans to begin stocking the kits this week. The kits are made by Pathway Genomics out of San Diego, California. The deal would be the first of its kind to put such tests in local pharmacies. But according to the FDA, there is no record that the test kits...

2010-04-28 10:42:00

MOUNTAIN VIEW, Calif., April 28 /PRNewswire/ -- Xlumena, a privately held provider of innovative technology for gastroenterologists/interventional endoscopists, today announced it has received clearance from the US Food and Drug Administration (FDA) to market its NAVIX(TM) Access Device. The NAVIX(TM) Device is an advanced endoscopy system, consisting of a multi-lumen catheter with a trocar, anchor and dilation balloons and two guidewire ports, designed to enable secure access, dilation...

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)...


Word of the Day
malpais
  • The ragged surface of a lava-flow.
'Malpais' translates from Spanish as 'bad land.'