Heron Therapeutics' long-acting local anesthetic reduced pain intensity and opioid use following surgery.
Alexion hit key endpoints for its experimental phase 3 drug ALXN1210 in patients with a life-threatening ultrarare blood disorder.
Implementation guidelines to support GxP in the cloud
Republicans plan to return to the topic and could push legislation through under rules that would only require them to get a majority.
Bellicum reported encouraging data for its BPX-501, but its U.S. program remains under a clinical hold.
For children diagnosed with rare diseases, traditional drug development timelines are not good enough. Collaborative partnerships are imperative to accelerate…
Regulatory officials took the action upon learning a cervical cancer patient developed respiratory failure and died after receiving the combination.
The proposal jibes with the wishes of the biopharma industry, but it remains to be seen whether the European Union is receptive to the idea.
Allergan originally expected the PDUFA date for ulipristal acetate to fall in the first half of the year.
The FDA hit Celgene with the refusal-to-file notice after concluding it failed to provide some preclinical and clinical pharmacology information.
ObsEva's nolasiban improved 10-week pregnancy rates after IVF in topline phase 3 data.
A late-stage study of Mesoblast’s off-the-shelf stem cell therapy for acute graft-versus-host disease (GVHD) has hit its main goal, setting up an imminent U.S…