The U.S. Food and Drug Administration has approved a companion diagnostic to detect gene mutation associated with a type of lung cancer. The U.S. health regulators on Tuesday cleared the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug Tarceva.   read on...

Seattle Genetics Inc. (NASDAQ: SGEN) said the U.S. health regulators have accepted for filing a supplement to the Biologics License Application (sBLA) supporting the use of ADCETRIS. The sBLA supports use of ADCETRIS for retreatment and extended duration of therapy in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL).   read on...

Biogen Idec Inc. (NASDAQ: BIIB) said the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) of ELOCTATE to treat hemophilia A. The company said ELOCTATE has the potential to improve adherence by reducing the number of intravenous injections needed to prevent bleeds.   read on...

GlaxoSmithKline Plc (NYSE: GSK) and Theravance Inc. (NASDAQ: THRX) announced approval from the U.S. health regulators for Breo Ellipta to treat chronic obstructive pulmonary disease (COPD).   read on...

AVEO Pharmaceuticals Inc. (NASDAQ: AVEO) reported that the U.S. Food and Drug Administration (FDA) advisory   read on...

Raptor Pharmaceutical Corp. (NASDAQ: RPTP) has won approval from the U.S. Food and Drug Administration   read on...

The first quarter results of Eli Lilly and Company (NYSE:LLY) illustrated the weakening of some key   read on...

The U.S. Food and Drug Administration (FDA) has launched a partnership to protect against counterfeit   read on...