THE US Food and Drug Administration (FDA) FDA charged Ranbaxy Laboratories’, Paonta Sahib facility, India has falsified data and test results in approved and pending drug applications.
13/03/2009
The Food and Drug Administration (FDA) publishes a listing of fraudulent 2009 H1N1 Influenza products that have not been approved for diagnosis, prevention or treatment.
27/11/2009
SYNTHEMED has announced that the US Food and Drug Administration (FDA) has approved the Pre-market Approval (PMA) application for REPEL-CV Adhesion Barrier.
13/03/2009
The Food and Drug Administration (FDA) has issued safety information regarding Negative Pressure Wound Therapy (NPWT) systems. Healthcare professionals have been notified by the US authority regarding deaths and serious complications associated with the use of these systems.
24/11/2009
The US Food and Drug Administration (FDA) A has finalised a paper titled 'Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects', which includes an attachment specifically for those involved in medical device trials and their management.
05/11/2009
CHINA Bio-Immunity Corporation (CHHB) has announced an update regarding the nationwide recall of its rabies vaccines.
13/03/2009
CSL Behring has been informed by the US Food and Drug Administration (FDA), that its RiaSTAP drug is entitled to seven years of ‘orphan-drug exclusivity.’
16/03/2009
CHEMIMAGE has announced it will aid generic drug makers achieve bioequivalence for nasal spray suspensions and inhalation products by providing a faster and more accurate way to determine drug particle size distribution in a drug product.
20/03/2009
VANDA Pharmaceuticals has compiled a report titled the “Common effect of antipsychotics on the biosynthesis and regulation of fatty acids and cholesterol supports a key role of lipid homeostasis in schizophrenia" for Schizophrenia Research, the official journal of the Schizophrenia International Research Society.
13/03/2009
US researchers have found that injections of the drug rituximab slows down beta cell destruction in the pancreas of patients newly diagnosed with type 1 diabetes for at least a year. The findings suggest a potential treatment option that might improve management and reduce long-term complications of the disease.
10/12/2009
University of Wollongong (UOW) researchers have developed a prostate cancer treatment device to enhance a US company’s Prostate Immobilizer Balloon System.
09/11/2009
A US biotech company, EDP Biotech (EDP), has developed a new technology for detecting early-stage colon cancer. EDP says the blood test is inexpensive and can detect colon cancer in its earliest, most curable stages.
16/02/2010
The US Food and Drug Administration (FDA) has approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children ages 6 weeks through 5 years. This new vaccine extends the protection to six more types of the disease-causing bacteria than its predecessor Prevnar.
01/03/2010
RESEARCHERS at Stanford University have published a comprehensive model representing the medical device development process, in an effort to help companies execute the bench-to-bedside process of product development.
02/07/2009
SCHERING-PLOUGH today announced that the US Food and Drug Administration (FDA) has approved new labelling for its PEGINTRON (peginterferon alfa-2b) and REBETOL (ribavirin, USP) combination therapy for treating chronic hepatitis C in patients three years of age and older with compensated liver disease.
16/03/2009
Medtronic has been selected as one of Massachusetts Institute of Technology (MIT) Technology Review's 50 most innovative companies. The company was recognised for its development and introduction of Deep Brain Stimulation (DBS) Therapy, which helps treat neurological conditions by delivering controlled electrical pulses to a specific part of the brain.
05/03/2010
US physicians will soon begin implanting a new medical device to improve breathing in patients with upper spinal-cord injuries or conditions that keep them from breathing independently.
30/11/2009
Bayer has begun a clinical Phase I study to treat non-Hodgkins lymphoma (NHL) using a patient-specific vaccine derived from tobacco plants.
12/02/2010
Menveo, a quadrivalent meningococcal conjugate vaccine from Novartis, has been approved by the US Food and Drug Administration (FDA) for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in people 11 to 55 years of age.
01/03/2010
A new stent graft can open vessels that become blocked or narrowed at the point where dialysis machines connect to the body. The stent has received approval from the US Food and Drug Administration.
16/02/2010