The Massachusetts attorney general says that members of the Sackler family that owns Purdue Pharma were instrumental in company efforts to push OxyCon...
AdvaMed says updates to its code of ethics on interactions with healthcare professionals will take effect next 1/1.
FDA accelerates by two months the PDUFA review date for Nabriva Therapeutics Contepo antibiotic.
FDA orders about 400 inspectors and support professionals to return to their posts from furlough to re-initiate high-risk surveillance inspections acr...
FDA commissioner Scott Gottlieb looks at ways the agency is coping with an upswing in cell and gene therapy INDs.
HHS secretary Alex Azar says progress is being made in reducing drug costs to consumers.
FDA grants Menlo Therapeutics a breakthrough therapy designation for serlopitant for treating pruritus associated with prurigo nodularis.
Aimmune Therapeutics mistakingly pays a $2.5 million user fee with a BLA submission for AR101, an investigational biologic oral immunotherapy for trea...