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Latest US Food and Drug Administration Stories

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2010-08-15 06:40:00

The US Food and Drug Administration approved a new, longer-lasting contraceptive pill on Friday that promises to prevent pregnancy up to five days after unprotected sex. The prescription drug, called Ella, made by French company HRA Pharma, will be sold in the United States by Watson Pharmaceuticals. It is the first emergency contraceptive approved in five years, after a long battle ended with limited over-the-counter sales and age checks by pharmacists for a rival pill. Ella has been...

2010-08-09 04:47:00

DENVER, Aug. 9 /PRNewswire/ -- Regenerative Sciences, Inc., a Colorado medical practice that specializes in the use of a person's own stem cells to help patients avoid more invasive orthopedic surgery, announced today that the US Food and Drug Administration (FDA) is seeking to enjoin the clinic physicians from practicing medicine using patients' own stem cells. The lawsuit will allow Regenerative Sciences to question the FDA's policy that adult stem cells can be classified as drugs when...

2010-08-06 08:20:00

SAN DIEGO and WOODCLIFF LAKE, N.J., Aug. 6, 2010 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) and Eisai Inc. announced today that the US Food and Drug Administration (FDA) has notified the company of the confirmed 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, which Arena discovered and has developed for weight management, is intended for...

2010-08-03 15:03:00

SAN DIEGO, Aug. 3, 2010 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today reported financial results for the second quarter ended June 30, 2010, and recent developments, including the successful Pre-Approval Inspection, or PAI, of the company's Swiss drug product manufacturing facility by the US Food and Drug Administration, or FDA. "We have recently achieved a number of important milestones, including the establishment of an agreement with Eisai for the...

2010-07-28 17:50:00

WILMINGTON, Del., July 28 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) today announced that the US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee recommended the FDA approve AstraZeneca's investigational drug ticagrelor for the reduction of thrombotic events in patients with Acute Coronary Syndromes (ACS). (Logo: http://photos.prnewswire.com/prnh/20091027/PH99766LOGO ) (Logo: http://www.newscom.com/cgi-bin/prnh/20091027/PH99766LOGO ) The...

2010-07-27 16:00:00

ANAHEIM, Calif., July 27 /PRNewswire/ -- Instrumentation Laboratory (IL) today announced that it has received clearance from the US Food and Drug Administration (FDA) to market the first-ever, rapid point-of-care, lab-quality blood test for measuring total bilirubin (tBili) in newborns. Bilirubin, a toxin, can, in high amounts, lead to irreversible brain injury in neonates. The new tBili assay is performed on IL's GEM Premier 4000 critical care analyzer. It allows clinicians to...

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2010-07-11 07:25:00

American scientists have developed "artificial blood" that could soon be used to treat soldiers who are wounded during battle. The artificial blood is created by taking cells from umbilical cords and using a machine to imitate the way bone marrow works to produce mass quantities of usable units of red blood cells. Producing the genetically-engineered blood is known as "Ëœblood pharming'. The program was launched in 2008 by the Pentagon's experimental sector, Darpa, to find a way...

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...