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Latest US Food and Drug Administration Stories

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...

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2010-10-09 07:40:00

"Pink Viagra," an experimental pill claiming to boost a woman's sex drive, has been scrapped by German maker Boehringer Ingelheim after failing to convince US regulators that the pill actually worked. "The decision was not made lightly, considering the advanced stage of development," CEO Andreas Barner told Reuters on Friday. The company had hoped the pill would have been a potential windfall aimed at premenopausal women with a persistent lack of sex drive. The move marked the failure of...

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2010-10-05 07:05:00

US government researchers announced Monday they have combined smallpox and anthrax vaccines into one vaccine, improving them and making them safer, faster-acting and more effective in case of a biological attack. "Although licensed vaccines are available for both smallpox and anthrax, because of inadequacies associated with each of these vaccines, serious concerns remain as to the deployability of these vaccines, especially in the aftermath of a bioterror attack involving these pathogens,"...

2010-10-01 08:41:00

SYDNEY and BEDMINSTER, N.J., Oct. 1 /PRNewswire/ -- QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) has today announced a Placement which raised A$14 million and which was significantly oversubscribed. The issue price under the Placement is A$0.85 per share, a 15% discount to the last closing price of QRxPharma shares on 28 September 2010 of A$1.00. The Company was pleased to accept some of the oversubscriptions from investors and increase the size of the placement from A$10 million to...

2010-09-30 17:10:00

MILWAUKEE, Sept. 30 /PRNewswire/ -- Today Mortara Instrument announced the award of two contracts from the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). The first award is a multi-year contract for continued maintenance of the FDA ECG Warehouse, and the second award supports the expansion of the ECG Warehouse to incorporate continuous 12-lead ECG recordings. Mortara has a long-standing relationship with the FDA, providing ECG algorithm tools and...


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