Pfizer and Merck KGaA took a step closer to becoming the fourth to market in the new checkpoint inhibitor space as they announce that the FDA has accepted for…

The FDA is unlikely to review Advanced Accelerator Applications’ gastroenteropancreatic neuroendocrine tumor drug Lutathera in time for the Dec. 28 PDUFA date.

We know it’s a top priority for Congress, but a group of panelists speaking at an “emergency briefing” in the U.S. Senate this week hosted by an anti-FDA legal…

The FDA has approved a label expansion for Genmab and Johnson & Johnson’s multiple myeloma drug Darzalex three months ahead of schedule.

The FDA has lifted the partial clinical hold it placed on trials of Aduro Biotech’s CRS-207 cancer vaccine last month.

Let’s be honest, 2016 was a mess of year, and one that many of us will be happy to see the back of. It saw the loss of a series of beloved actors, actresses…

An FDA “Breakthrough” tag, which has been around since 2012, was once a highly coveted badge that in essence allows the regulator to help speed up development…

A law firm is suing Clovis Oncology over statements about the safety and efficacy of its now-scrapped lung cancer candidate rociletinib.

Regulatory