The U.S. Food and Drug Administration today approved Stivarga (regorafenib) to treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body (metastatic).

The U.S. Food and Drug Administration announced the formation of an internal task force that will support the development of new antibacterial drugs, a critical public health care goal and a priority for the agency.

The U.S. Food and Drug Administration today approved Lucentis (ranibizumab injection) for the treatment of diabetic macular edema (DME), a sight-threatening eye disease that occurs in people with diabetes.

The U.S. Food and Drug Administration today approved the first generic versions of Singulair (montelukast sodium) for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies.

U.S. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg announced the agency has approved or tentatively approved a total of 152 antiretroviral drugs in association with the President's Emergency Plan for AIDS Relief (PEPFAR) to treat those infected with HIV/AIDS in countries that lack the tools needed to fight the AIDS epidemic.

The European Medicines Agency has launched its website on suspected side-effect reportsExternal link icon for medicines authorised in the European Economic Area (EEA) in the remaining 22 official European Union (EU) languages.

The European Medicines Agency has begun publishing suspected side effect reports for medicines authorised in the European Economic Area (EEA) on a new public website. The reports come directly from the European Union (EU) medicines safety database EudraVigilance, and are one of the many types of data used by regulators to monitor the benefits and risks of a medicine once authorised.