Cempra announced what looked inevitable on Thursday morning: a complete response letter for solithromycin.

Anthera saw its shares tank after hours as the biotech announced yet another failed study, this time for its late-stage trial for a GI candidate in cystic…

Biotech, like all other industries and the British public, is no closer to knowing what life will look like post-Brexit than it was on June 24.

At almost 1,000 pages, the 21st Century Cures Act is quite literally a weighty piece of legislation that will have far-reaching consequences for pharma in 2017…

Manufacturing issues are to blame again for another delayed 2016 approval as Roche announces its speedy FDA review was for nought as it must now wait another 3…

The FDA has granted priority review status and a June 30 PDUFA date to Tesaro’s PARP inhibitor niraparib.

Clovis Oncology has won approval for rucaparib in a particular population of ovarian cancer patients.

Loxo Oncology reckons it could be just a year or so away from being able to file for approval of its lead drug, just months after reporting phase 1 data.

Regulatory