FDA Panel to Consider At-Home HIV Test
Comments (0)Posts tagged: fda
Comments (0)
Congress wrestles with medical research funding, FDA approval processes
Medical research advocates warn Congress about the dire impact that automatic spending cuts scheduled to take effect in January would have on efforts to control disease and develop life-saving treatments. Also in the news, how the concept of "fast-track" Food and Drug Administration approvals is playing on Capitol Hill.
FDA clears MAQUET’s new MEGA larger volume intra-aortic balloon catheters
MAQUET Cardiovascular LLC, a leading provider of cardiovascular technologies, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new MEGA 7.5Fr. 30cc and 40cc intra-aortic balloon (IAB) catheters. These new, larger volume catheters will allow clinicians to provide patients with greater ...
FDA Issues Multiple Sclerosis Drug Alert
MONDAY, May 14 (HealthDay News) -- The multiple sclerosis drug Gilenya (fingolimod) should not be given to patients with certain pre-existing or recent heart conditions or stroke, or those taking certain medications to correct heart rhythm problems, says a U.S. Food and Drug Administration safety announcement issued Monday. The ...
FDA ADAC recommends approval of Quad for HIV-1 infection
Gilead Sciences, Inc. today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 1 in support of approval of the Quad, a complete single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, for the treatment of HIV-1 infection ...
FDA Panel Gives Blessing to New Weight-Loss Drug
THURSDAY, May 10 (HealthDay News) -- An advisory panel to the U.S. Food and Drug Administration on Thursday recommended approval of the weight-loss medication lorcaserin, even though concerns remain about cardiovascular side effects. If the agency were to give the nod to the drug, lorcaserin would become the first ...
FDA Issues Warning On Unproven MS Treatment
FDA has issued an alert to healthcare professionals and those suffering from multiple sclerosis. An avante garde procedure used to treat suffers of chronic cerebrospinal venous insufficiency (CCSVI), has been deemed unsafe, causing potential injury and even death. The procedure, known as liberation therapy or liberation procedure, uses stents, also ...
Obesity Drug Lorcaserin Gets Positive Vote From FDA Panel
Lorcaserin, an investigational obesity drug, was given a positive recommendation by the Endocrinologic and Metabolic Drugs Advisory Committee, which advises the Food and Drug Administration (FDA). The Committee voted 18 to 4 in favor, with one abstention, in advising the FDA whether to approve the medication for obese or overweight ...
NBHA commends FDA for continuing investigation of bisphosphonate treatment for osteoporosis
In response to today's Perspective pieces published in the New England Journal Of Medicine, the National Bone Health Alliance (NBHA), a public-private partnership bringing together the expertise and resources of its 42 members from the private and non-profit sectors to collectively advance bone health and prevent disease, commends the U.S. ...
HIV Prevention Pill Receives FDA Panel Support
On Thursday, a panel of outside experts that advises the US Food and Drug Administration (FDA) voted to support approval of the daily pill Truvada to prevent HIV in healthy people. The FDA is not obliged to follow the advice of its Antiviral Drugs Advisory Committee, but ...
HIV prevention drug receives FDA panel’s backing
The drug has already been approved as a treatment for HIV/AIDS. The FDA is expected to decide about approval by June 15.
BIOTRONIK receives FDA approval for new Lumax 740 ICDs and CRT devices
BIOTRONIK, a leading manufacturer of innovative medical technology, has received FDA approval of its new Lumax 740 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds). Lumax 740 helps physicians monitor and treat their patients' arrhythmias and heart failure under ever-changing medical conditions.