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Latest US Food and Drug Administration Stories

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...

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...


Word of the Day
baudekin
  • A rich embroidered or brocaded silk fabric woven originally with a warp of gold thread.
'Baudekin' seems to be an alternative form of 'baldachin,' from the Italian 'Baldacco,' Baghdad, the city where the material was made.
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