Medical equipment industry
TriPath Imaging, Inc. has received 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 protein. This clearance expands the utility of VIAS as an aid to the clinical assessment of breast cancer. The system,
Medical equipment industry
Scott + Scott, LLC, a law firm specializing in complex litigation, including securities fraud, was surprised to learn that a New York Times Freedom of Information Act Request to the Food and Drug Administration (FDA) for information on faulty Guidant defibrillators was denied. The information sought by the Times concerned the
Medical equipment industry
St. Jude Medical, a leading manufacturer of medical devices, has received approval from the U.S. Food and Drug Administration (FDA) for its SJM Biocor(R) and Biocor(R) Supra family of stented tissue valves. This approval marks a significant milestone for the company, allowing it to expand its portfolio
Pharmaceutical industry
Aurobindo Pharma Limited, a leading pharmaceutical company, has received approval from the US Food and Drug Administration (FDA) for Efavirenz tablets, 600 mg, marking the first generic approval of the company ahead of the rest of the industry. This significant development opens up a substantial opportunity for Aurobindo in Africa
Pharmaceutical industry
Aurobindo Pharma Limited, a leading pharmaceutical company, has received approval from the US Food and Drug Administration (FDA) for Efavirenz tablets, 600 mg, marking the company's first generic approval ahead of the rest of the industry. This significant milestone opens up opportunities for Aurobindo in Africa under the
Medical equipment industry
The U.S. Food and Drug Administration (FDA) has issued an "approvable letter" to Mentor Corporation for their application for silicone gel-filled breast implants, outlining conditions the company must meet for full approval. However, patient advocates and experts are warning that the safety data for these devices are
Medical equipment industry
The U.S. Food and Drug Administration (FDA) is notifying healthcare providers and patients about a voluntary recall of certain pacemakers manufactured by Guidant Corporation. These pacemakers have a seal that can leak, allowing moisture to damage the electronic circuits, potentially leading to device failure, loss of consciousness, heart failure,
Pharmaceutical industry
Senate Majority Leader Bill Frist is putting the pharmaceutical industry on notice that he expects curbs on direct-to-consumer advertising of prescription drugs. Frist blames the ads for contributing to rising health care costs, and is seeking a two-year moratorium on advertising for new drugs. He also wants a government audit
Pharmaceutical industry
CoTherix, Inc., has initiated a phase II trial for its marketed product, Ventavis (iloprost) Inhalation Solution, aiming to expand its indication to include pulmonary hypertension (PH) associated with idiopathic pulmonary fibrosis (IPF). The double-blind, placebo-controlled trial, known as the ACTIVE trial, will enroll approximately 50 patients at 15 sites in
Pharmaceutical industry
The U.S. Food and Drug Administration's (FDA) Antiviral Drugs Advisory Committee has recommended the approval of the investigational anti-HIV drug tipranavir, a nonpeptidic protease inhibitor that requires boosting with low-dose ritonavir and must be used in combination with other antiretroviral agents. The committee's positive recommendation
Pharmaceutical industry
Ivax Corporation, a leading pharmaceutical company, has received significant regulatory approvals for its two key products: fluticasone nasal spray and levofloxacin tablets. The company's fluticasone nasal spray has been granted final marketing authorization by the U.K. Medicine and Healthcare Products Regulatory Agency, while its levofloxacin tablets have
Pharmaceutical industry
The Food and Drug Administration is considering the approval of BiDil, a heart failure medication developed by NitroMed, which could become the first drug in the United States to be approved specifically for black people. According to a study, BiDil showed a significant benefit in reducing mortality rates among black
