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Latest US Food and Drug Administration Stories

2011-01-20 06:00:00

PRINCETON, N.J., Jan. 20, 2011 /PRNewswire/ -- Soligenix, Inc. (OTC Bulletin Board: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to RiVax(TM) for the prevention of ricin intoxication. RiVax(TM) is a proprietary vaccine that contains a recombinant subunit of the A chain of ricin toxin which induces ricin neutralizing antibodies in humans and animals. The US Orphan...

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2010-12-31 06:30:00

Two American companies broke new ground this year by gaining regulatory approval to begin the first experiments using embryonic stem cells on people suffering from spinal cord injuries and blindness. The use of the cells, which have been hotly debated for years, can transform into nearly any cell in the human body, which could lead to finding ways to eliminate such ailments as Parkinson's disease, diabetes, heart disease, paralysis, and may even help fight aging. As scientists find ways to...

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2010-12-29 06:15:00

A US food safety agency warned consumers on Monday against eating alfalfa sprouts and spicy sprouts (a mixture of three types of sprouts) from Tiny Greens Organic Farm in Urbana, Illinois, after reports surfaced that the foods were tainted with salmonella, possibly behind the 89 cases found throughout the Midwest. USA Today received a call from Tiny Greens Organic Farm owner Bill Bagby on Monday evening. Bagby, who was stranded at a family reunion in North Carolina, told USA Today that the...

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...


Word of the Day
attercop
  • A spider.
  • Figuratively, a peevish, testy, ill-natured person.
'Attercop' comes from the Old English 'atorcoppe,' where 'atter' means 'poison, venom' and‎ 'cop' means 'spider.' 'Coppa' is a derivative of 'cop,' top, summit, round head, or 'copp,' cup, vessel, which refers to 'the supposed venomous properties of spiders,' says the OED. 'Copp' is still found in the word 'cobweb.'
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