Medigene has been given a green light in Germany to start human trials of MDG1011, the lead candidate to come out of its modified T-cell program.

The FDA has issued a complete response letter for Apricus’ topical ED drug Vitaros again, sparking a massive after-hours slump in its share price.

Tetraphase's lead candidate, eravacycline, failed to best Merck’s ertapenem in complicated UTIs.

Array's combo treatment nearly doubled survival in melanoma patients compared to Roche’s Zelboraf.

Bellicum suffered the setback after the FDA learned of three cases of brain damage possibly related to adjunct T-cell therapy BPX-501.

The precipitous drop in the amount of space available to the EMA will force the agency to hold meetings off-site.

If approved, Theravance and Mylan’s nebulized COPD drug would be the first once-daily, nebulized bronchodilator for COPD.

The FDA recommendation leaves Aradigm potentially needing to raise a sizable sum of money at a time when its stock is plumbing new depths.