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Latest US Food and Drug Administration Stories

2010-07-08 05:00:00

AMSTERDAM, July 8 /PRNewswire/ -- Biopharmaceutical Company Kiadis Pharma announced today that it has received approval for its Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to start the pivotal clinical study for its product ATIR(TM) in the United States. Kiadis Pharma is currently enrolling patients in a multinational, pivotal clinical study at hospitals in Europe and Canada. With the approval of the IND, US hospitals will also participate in...

2010-06-17 16:10:00

WAYNE, N.J., June 17 /PRNewswire/ -- In a June 16, 2010 proceeding before Judge Virginia Kendall in US Federal Court in the Northern District of Illinois, Teva Pharmaceuticals USA Inc. admitted that the Physician Prescribing Information included with packages of its oral contraceptive Gianvi(TM), falsely claimed that the ethinyl estradiol in the product was stabilized by Bayer's patented "betadex as a clathrate" formulation, and in fact, that Gianvi does not have Bayer's patented...

2010-06-10 19:15:00

EAST HANOVER, N.J., June 10 /PRNewswire/ -- Today, an advisory committee of the US Food and Drug Administration (FDA) recommended approval of FTY720 (fingolimod) for the treatment of patients with relapsing multiple sclerosis, the most common form of the disease. The FDA has the option of seeking the advice of one of its advisory committees as it reviews and decides whether to approve a new treatment. The committee voted unanimously that FTY720 demonstrated substantial efficacy in...

2010-06-05 16:39:00

EAST HANOVER, N.J., June 5 /PRNewswire/ -- Novartis Pharmaceuticals Corporation ("Novartis") announced today that results from a Phase II study show Afinitor® (everolimus) tablets is the first medication in a clinical trial to decrease the size of subependymal giant cell astrocytomas (SEGAs), benign brain tumors associated with tuberous sclerosis (TS) (1,2). In this study of 28 patients presented today at the 46th American Society of Clinical Oncology (ASCO) annual...

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...


Word of the Day
snash
  • To talk saucily.
  • Insolent, opprobrious language; impertinent abuse.
This word is Scots in origin and probably imitative.