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

Osaka-based Santen has seen some positives mixed with some negatives for its phase 3 ophthalmology program, but believes it has enough to warrant an NDA with…

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

Less than a month after being hit with a partial clinical hold on its head and neck cancer study, AstraZeneca has gotten a reprieve after the U.S. regulator…

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.

Spectrum has said in a SEC filing that the U.S. regulator has rejected its application for Qapzola (apaziquone) for bladder cancer.

Regulatory