As the saying goes, what goes up must come down, and to the biopharma industry's chagrin, that’s exactly what happened to new drug approvals in 2016. Last…

Dynavax has laid off 38% of its workforce in response to last year’s regulatory setback and its failure to find a partner.

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…

With 2016’s wild-card Republican primary candidate becoming 2017’s POTUS, the list of outstanding questions confronting biotech this year is particularly long.

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…

It’s the time of year for editors to look ahead and attempt to predict, based on the patterns of the past 12 months, what the next trip around the sun will…

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.

Regulatory