Pharmaceutical industry
South Korea's health watchdog has stated that it has received no information indicating that patients exhibit side effects such as hallucinations that might lead to suicide from the antiviral drug Tamiflu. The Korean Food and Drug Administration (KFDA) reported 17 cases of side effects since the drug'
Pharmaceutical industry
Noven Pharmaceuticals, Inc., a US-based biopharmaceutical company, announced on September 28, 2005, that the US Food and Drug Administration (FDA) has advised the company that the FDA does not expect to approve Noven's Abbreviated New Drug Application (ANDA) for a generic version of Duragesic(R) (fentanyl transdermal system)
Pharmaceutical industry
Merck & Co. testified that predicting a warning label about the health risks of its Vioxx painkiller could cut annual sales by half. This estimate was made in 2001 while Merck was fighting regulations to force disclosure of Vioxx's health risks on the product label. The company'
Medical equipment industry
The Food and Drug Administration (FDA) has given conditional approval to Inamed Corp. for the sale of its silicone gel-filled breast implants, pending the resolution of outstanding safety concerns. This decision comes after the company addressed the primary safety concerns raised by a federal advisory panel in April. The approval
Medical equipment industry
The US Food and Drug Administration's conditional approval of Santa Barbara-based Inamed Corp.'s silicone gel-filled implants marks a significant step towards bringing back the use of silicone breast implants in the US market, which has been banned for the past 13 years due to health concerns.
Pharmaceutical industry
Recent votes by federal advisers indicate that safety concerns won't slow down approval of new therapies, contradicting expectations that the Food and Drug Administration would become more cautious following the Vioxx recall. Despite fears that the agency would put the brakes on new drug approvals, the FDA'
Pharmaceutical industry
Sandoz, the generic arm of Swiss pharmaceutical company Novartis, has taken legal action against the US Food and Drug Administration over its delayed decision on the company's generic human growth hormone product, Omnitrope. The product was filed for approval in July 2003, but the FDA has yet to
Medical equipment industry
The Food and Drug Administration's (FDA) delayed response to a flawed heart defibrillator has been criticized for costing a college student's life, highlighting the agency's alleged complicity in the silence. A report by Barry Meier revealed that the FDA received a report from the
Medical equipment industry
Boston Scientific Corporation (BSX) has announced the U.S. Food and Drug Administration (FDA) approval for the Wingspan Stent System with Gateway PTA Balloon Catheter, a device designed to treat atherosclerotic lesions in brain arteries. The Wingspan Stent System is the only device available in the U.S. for treating
United States. Food and Drug Administration
A promising new drug, maraviroc, has shown encouraging results in early-stage clinical trials for the treatment of HIV/AIDS. Presented at the 3rd International AIDS Society Conference on Pathogenesis and Treatment, the research indicates that maraviroc is well-tolerated and significantly decreases patient levels of HIV in asymptomatic patients. This investigational
United States. Food and Drug Administration
Endologix, Inc., a company specializing in minimally invasive treatments for vascular diseases, has received approval from the U.S. Food and Drug Administration (FDA) to enroll patients in a clinical trial utilizing the Powerlink System to treat abdominal aortic aneurysm (AAA) in patients with large diameter aortic necks. The Powerlink
Medical equipment industry
TriPath Imaging Inc., a leader in molecular diagnostics, has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Ventana Image Analysis System (VIAS) when used with tissues stained for HER-2/neu. This latest clearance expands the utility of VIAS as
