FDA Commissioner Margaret A. Hamburg, M.D., said she is revoking the agency's approval of the breast cancer indication for Avastin (bevacizumab) after concluding that the drug has not been shown to be safe and effective for that use.

The European Medicines Agency is reviewing the latest available data on the cardiovascular safety of non-selective NSAIDs (non-steroidal anti-inflammatory drugs).

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has reviewed further data from Finland on the suspected link between narcolepsy in children and adolescents and Pandemrix.

The European Medicines Agency has confirmed that the benefits of Avastin in combination with paclitaxel outweigh its risks and that this combination remains a valuable treatment option for patients suffering from metastatic breast cancer.

The U.S. Food and Drug Administration announced that the agency is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use.

The European Medicines Agency and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) have launched the ENCePP E-Register of Studies. This electronic register is a publicly accessible resource for the consultation of pharmaco-epidemiological and pharmacovigilance studies conducted by academic centres and other research organisations.

The U.S. Food and Drug Administration says Vigor-25, a product marketed as a natural dietary supplement to enhance male sexual performance, should not be purchased or used because it contains sildenafil, the active ingredient in the prescription drug Viagra.