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Latest US Food and Drug Administration Stories

health-082611-001
2011-08-26 05:45:50

  The US Food and Drug Administration (FDA) has banned papaya´s from all of Mexico´s growing regions from entering the US due to an outbreak of salmonella. According to MSNBC's JoNel Aleccia, an FDA investigation found more than 15 percent of fresh papayas entering the US from Mexico were contaminated with the bacteria. The investigation occurred between May 12 and August 18 and was instigated because of an outbreak that sickened over 100 people in 23 states, sending...

health-082511-004
2011-08-25 09:27:14

  The US Food and Drug Administration (FDA) has given approval for Allergan, the maker of Botox, to market the drug to treat a specific kind of overactive bladder condition, Reuters is reporting. After receiving similar approval in Europe earlier this month, US regulators are allowing Botox to be injected into the bladder to treat those who lose bladder control because of damage to the nervous system through conditions such as multiple sclerosis or spinal cord injury. Botox´...

2011-08-09 06:00:00

SAN DIEGO and WOODCLIFF LAKE, N.J., Aug. 9, 2011 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced today results from a Pathology Working Group's (PWG) re-adjudication of female rat mammary tumor diagnoses from a two-year rat carcinogenicity study of lorcaserin. Arena convened the PWG in response to the lorcaserin Complete Response Letter (CRL), which questioned the certainty of the female rat mammary tumor classifications. The PWG reviewed relevant...

2011-08-02 06:00:00

SAN DIEGO and WOODCLIFF LAKE, N.J., Aug. 2, 2011 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced today the completion of a clinical study that measured lorcaserin concentrations in human cerebrospinal fluid (CSF) and plasma and related data analyses. The study was conducted to provide additional data that may be informative for determining the human relevance of the observation of brain astrocytoma in male rats. Using the results of this study and...

2011-07-19 09:30:00

TITUSVILLE, N.J., July 19, 2011 /PRNewswire/ -- Janssen Therapeutics, Division of Janssen Products, LP, presented today 96-week findings from two pivotal Phase 3 clinical trials, known as ECHO and THRIVE, comparing the efficacy, safety and virology profile of its non-nucleoside reverse transcriptase inhibitor (NNRTI) EDURANT(TM) (rilpivirine) tablets versus efavirenz (EFV) in antiretroviral treatment-naive, HIV-1-infected adults. The pooled analysis at 96 weeks showed that 78 percent of...

ad5a96de2d69f4016c6ceb1d7777d9b8
2011-06-21 12:45:00

The US Food and Drug Administration (FDA) today released nine new warning labels that are now mandatory to include onto packs of cigarettes in the most drastic change in smoking-related advertising in 25 years, AP is reporting. The graphic labels depict in startling details the negative effects of prolonged smoking. Among the images to appear are rotting and diseased teeth and gums and a man with a tracheotomy smoking a cigarette. Also included are the corpse of a smoker, diseased lungs, and...

2011-06-16 08:00:00

WORCESTER, Mass. and TORONTO, June 16, 2011 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB: GNBT) (www.generex.com) today issued a synopsis of the update on the clinical and regulatory program for Generex Oral-lyn(TM), the Company's proprietary buccal insulin spray product, provided at the annual meeting of the Company's stockholders held in New York City on June 8, 2011. At that meeting, the current status, clinical study plans, and major market registration pathway for Generex...

2011-06-01 07:03:00

HERZLIYA, Israel, June 1, 2011 /PRNewswire-FirstCall/ -- On May 29, 2011 XTL has announced that its rHuEPO (recombinant human erythropoietin) drug which is currently in preparations for phase 2 clinical trial, has been granted an Orphan-drug designation by the US Food and Drug Administration (FDA) for treatment of Multiple Myeloma blood cancer. An orphan drug is defined as a drug treatment for an illness that affects a relatively small number of people in the population. In the US,...

2011-05-05 17:50:00

EAST HANOVER, N.J., May 5, 2011 /PRNewswire/ -- Novartis Pharmaceuticals Corporation ("Novartis") announced today that the US Food and Drug Administration (FDA) approved Afinitor® (everolimus) tablets for the treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease(4). This marks the first approval of a treatment for this patient population in the US in nearly 30 years(5). The...


Word of the Day
call-note
  • The call or cry of a bird or other animal to its mate or its young.
'Call-note' is newer than 'bird-call,' which originally referred to 'an instrument for imitating the note of birds' but now also refers to 'the song or cry of a bird.'
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