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Latest US Food and Drug Administration Stories

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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...

2010-09-23 10:48:00

LONDON, Sept. 23 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE and LSE: GSK) confirms that following a review of Avandia® (rosiglitazone maleate) by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), each agency has today announced their individual regulatory decisions and the resulting actions. In the European Union*, the EMA has suspended the marketing authorization for all rosiglitazone-containing medicines (Avandia,...

2010-09-21 15:01:00

SAN DIEGO, Sept. 21 /PRNewswire-FirstCall/ -- Gen-Probe (Nasdaq: GPRO) announced today that the Company has submitted a Premarket Approval Application (PMA) to the US Food and Drug Administration (FDA) for its PROGENSA® PCA3 assay, a new molecular test that may help determine the need for repeat biopsies in men suspected of having prostate cancer. "Based on the results of our US clinical study, data from numerous peer-reviewed publications, and our European commercial...

2010-09-16 15:42:00

SAN DIEGO, and WOODCLIFF LAKE, N.J., Sept. 16 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) and Eisai Inc. announced today that the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 9 to 5 that the available data do not adequately demonstrate that the potential benefits of lorcaserin outweigh the potential risks, when used long-term in a population of overweight and obese individuals to allow marketing approval....

2010-09-13 07:00:00

SAN DIEGO, Sept. 13, 2010 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced it will host a conference call and webcast on Friday, September 17, 2010, at 7:00 a.m. Eastern Time (4:00 a.m. Pacific Time) following the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee meeting. The committee is scheduled to meet on September 16, 2010, to review the lorcaserin New Drug Application (NDA). Lorcaserin, which Arena...

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2010-08-27 06:40:00

A recall of more than a half billion contaminated eggs last week from two Iowa producers may have been caused by chicken feed tainted with salmonella bacteria, US regulators said on Thursday. "We've received confirmation of salmonella-positive ... with the DNA fingerprint that matches the outbreak fingerprint for the feed samples that were provided to pullet at the Wright County egg farms at Hillandale Farms," said Sherri McGarri, foodborne outbreak specialist at the US Food and Drug...

2010-08-19 09:00:00

THE WOODLANDS, Texas, Aug. 19 /PRNewswire/ -- US Oncology, Inc., the nation's leading integrated oncology company, announced today that in less than two decades it has played a role in the development of 42 novel cancer therapies approved by the US Food and Drug Administration (FDA). (Logo: http://photos.prnewswire.com/prnh/20100517/DA06089LOGO) (Logo: http://www.newscom.com/cgi-bin/prnh/20100517/DA06089LOGO) Tasigna® (nilotinib) capsules, a medicine developed by...

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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...


Word of the Day
virgule
  • A punctuation mark (/) used to separate related items of information.
  • A little rod; a twig.
This word comes from the Late Latin 'virgula,' accentual mark, a diminutive of 'virga,' rod.
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