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Latest US Food and Drug Administration Stories

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...

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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...

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2011-04-20 06:40:00

The US Food and Drug Administration (FDA) is requiring drugmakers to provide educational material to help train physicians on the correct use of drugs as part of the government's new plan to fight prescription drug abuse in the United States. Prescription drug overdose is the fastest-growing drug problem in the country. It is higher than the number of overdoses from the crack cocaine epidemic of the 80s and the black tar heroin epidemic of the 70s combined, the Obama administration says....

2011-04-12 13:59:00

EAST HANOVER, N.J., April 12, 2011 /PRNewswire/ -- Novartis Pharmaceuticals Corporation ("Novartis") announced today that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of Afinitor® (everolimus) tablets for the treatment of patients with advanced neuroendocrine tumors (NET) of pancreatic origin. The recommendation was provided after presentation of data from the everolimus RADIANT (RAD001 In Advanced...

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2011-04-01 07:40:00

Drug maker GlaxoSmithKline released a new report detailing that its antidepressant Paxil could potentially make people with major depression more likely to become suicidal. But in clinical trials, the company found that attempted suicide rates were relatively low -- 0.34 percent for those using Paxil vs. 0.05 percent for those taking a placebo pill. The report also states that the findings couldn't rule out that the difference was due to chance. "The scientific evidence does not establish...

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2011-03-26 08:45:00

A drug from Bristol-Myers Squibb Co. shown to help prolong the lives of people suffering from advanced skin cancer has been approved by the US Food and Drug Administration on Friday.The injectable drug, called Yervoy (ipilimumab), is used for late-stage melanoma. Bristol-Myers Squibb aims to use the drug to harness the body's immune system to target and attack melanoma tumors."Yervoy is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live...

2011-03-25 09:49:00

WAYNE, N.J., March 25, 2011 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. today announced that interim results from a large, prospective, observational cohort safety study offer insights into the increased risk of venous thromboembolism (VTE), or blood clots, which is a well-established risk in women who use combination oral contraceptives (COCs), also known as "the Pill". Specifically, the new data provides healthcare providers with information regarding when the VTE risk...