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Latest US Food and Drug Administration Stories

2010-12-22 06:30:00

SAN DIEGO and WOODCLIFF LAKE, N.J., Dec. 22, 2010 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) and Eisai Inc. announced today the completion of an end-of-review meeting with the US Food and Drug Administration (FDA) for the lorcaserin New Drug Application (NDA). "The meeting discussions reinforce our position that we have a path forward to seek FDA approval of lorcaserin," said Jack Lief, Arena's President and Chief Executive Officer. "Based on guidance we have received...

2010-12-21 17:00:00

SAN DIEGO, Dec. 21, 2010 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today that Jack Lief, Arena's President and Chief Executive Officer, will host a conference call and webcast tomorrow, Wednesday, December 22, 2010, at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to provide an update following the completion of an end-of-review meeting with the US Food and Drug Administration (FDA) for the lorcaserin New Drug Application (NDA). The conference call may be...

2010-12-16 19:59:00

WILMINGTON, Del., Dec. 16, 2010 /PRNewswire/ -- AstraZeneca (NYSE: AZN) announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for ticagrelor (BRILINTA(TM)). (Logo: http://photos.prnewswire.com/prnh/20091027/PH99766LOGO ) In the CRL, the FDA requested additional analyses of the PLATO data. The agency did not request that additional studies, including clinical studies, be conducted as a prerequisite...

2010-12-08 15:01:00

SAN DIEGO, Dec. 8, 2010 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) announced today that the US Food and Drug Administration (FDA) has cleared for marketing the Prodesse ProAdeno(TM)+ assay, a multiplex real-time polymerase chain reaction (PCR) in vitro diagnostic test for the qualitative detection of human adenovirus. "FDA clearance of our ProAdeno+ assay adds to the Prodesse portfolio of molecular tests for respiratory infectious diseases," said Eric Tardif,...

2010-12-02 14:16:00

WILMINGTON, Del., Dec. 2, 2010 /PRNewswire/ -- AstraZeneca (NYSE: AZN) today announced the outcome of the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee meeting to discuss the New Drug Application (NDA) for AstraZeneca's investigational drug, vandetanib, for the treatment of patients with unresectable (non-operable) locally advanced or metastatic medullary thyroid cancer (MTC). (Logo: http://photos.prnewswire.com/prnh/20091027/PH99766LOGO ) The Advisory...

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2010-12-02 08:55:00

The US Food and Drug Administration (FDA) has announced a recall of Mylanta and AlternaGel liquid antacids, making it the latest in a long line of Johnson & Johnson affiliated products to face a recall this year. The products, which are manufactured by Johnson & Johnson-Merck Consumer Pharmaceuticals, Co. (JJMCP), are being recalled due to a labeling issue. Each of the 12 varieties of Mylanta and the one version of AlternaGel affected by the notice contain a trace amount of alcohol...

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2010-12-01 06:23:26

The US Senate has passed the largest overhaul of the food safety system in more than 70 years Tuesday, in response to massive recalls that have plagued the United States, such as last year's recall of more than 500 million eggs after a salmonella outbreak. The Senate passed the bill with a 73-25 in favor vote. The House of Representatives endorsed a different version of the bill in July 2009. With post-election sessions due to end by mid-December, lawmakers have less than a month to resolve...

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2010-11-29 08:50:00

A Senate bill set to pass this week would give the US Food and Drug Administration (FDA) the authority to conduct inspections more frequently and order a recall of tainted products, according to a Monday article by Associated Press (AP) writer Mary Claire Jalonick. Currently, the FDA has to negotiate with food manufacturers in order to issue a voluntary product recall. In addition to changing that process, Jalonick reports that the proposed legislation would also require "food manufacturers...

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2010-11-21 07:35:00

Kentucky-based Xanodyne Pharmaceuticals has pulled its popular narcotic painkiller, Darvon, from the drug market because it may cause fatal heart rhythms, the US Food and Drug Administration (FDA) announced on Friday. The FDA said it asked Xanodyne to stop selling Darvon and Darvocet after recent data confirmed that the active ingredient, propoxyphene, could cause serious and possibly fatal heart abnormalities. The new decision leaves patients with even fewer safe options to manage pain,...

2010-10-23 01:14:00

SAN DIEGO and WOODCLIFF LAKE, N.J., Oct. 23, 2010 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) and Eisai Inc. announced that the US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding Arena's New Drug Application (NDA) for lorcaserin. Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (Body Mass Index, or BMI, >/= 30) or patients who are overweight (BMI...


Word of the Day
abrosia
  • Wasting away as a result of abstinence from food.
The word 'abrosia' comes from a Greek roots meaning 'not' and 'eating'.