Actavis receives FDA approval for Ropinirole ER Tablets
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Drug Approval Faster In US FDA Than Its European Or Canadian Counterparts
Although the drug approval process in the U.S. has been perceived as too slow, the nation approves new drug treatments faster and earlier than Europe and Canada, according to researchers at Yale School of Medicine. The study, conducted by Nicholas Downing, a second-year medical student and Joseph S. Ross, ...
US FDA Ahead Of Canada, Europe In Drug-Approval Race
The U.S. Food and Drug Administration (FDA) generally approves drug therapies faster and earlier than its counterparts in Canada and Europe, according to a new study by Yale School of Medicine researchers. The study counters perceptions that the drug approval process in the United States is especially slow. Led by ...
Mylan receives final FDA approval for Clopidogrel Tablets ANDA
Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Clopidogrel Tablets USP, 75 mg and 300 mg.
Bristol-Myers Squibb receives FDA approval for Devens facility to produce ORENCIA
Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has approved the company's biologics manufacturing facility in Devens, Massachusetts for commercial production of ORENCIA.
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 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 ...
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.
Drug Safety Monitoring Should Be Expanded After Approval
Pharmaceutical drugs approved by the Food and Drug Administration (FDA) but later re-called from the market - such as the antidiabetic drug Avandia and pain-reliever Vioxx - were the impetus for an Institute of Medicine committee report, recommending that the FDA take proactive steps to continue monitoring drugs' safety after ...
FDA approval of TDF/FTC as PrEP for HIV infection receives support
In public comments submitted this week, a group of 14 leading HIV/AIDS and health organizations stated their support for Food and Drug Administration (FDA) approval of emtricitabine/ tenofovir disoproxil fumarate (TDF/FTC or Truvada) as pre-exposure prophylaxis (PrEP) to prevent HIV infection in adult men and women.
German BfArM grants Moberg Derma approval to initiate Limtop phase II actinic keratosis trial
The German Federal Institute for Drugs and Medical Devices (BfArM) has granted Moberg Derma approval to initiate a clinical phase II trial for Limtop. The aim is to evaluate the efficacy and safety of three different dose regimens of Limtop in a study involving 96 patients with Actinic Keratosis (AK) ...
Pfizer receives FDA approval for Elelyso to treat Type 1 Gaucher disease
The U.S. Food and Drug Administration today approved Elelyso (taliglucerase alfa) for long-term enzyme replacement therapy to treat a form of Gaucher disease, a rare genetic disorder.