Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Allergans Ubrelvy (ubrogepant), indicated for t...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for TherOxs PMA for the TherOx Downstream System, i...
Three patient advocacy groups sue HHS and the Centers for Medicare and Medicaid Services over their support for insurance companies and pharmacy benef...
Beam Therapeutics says it will complete studies requested by FDA as part of a clinical hold on a Beam-201 cancer treatment IND and submit its response...
FDA warns Missoula, MT-based Elite One Source Nutritional Services about dietary supplement CGMP and misbranding violations.
The Medical Device Information Consortium publishes information from a working group looking at the benefits of and approaches to using patient prefer...
FDA commissioner Robert Califf says the agency has launched a drug overdose prevention framework with four overarching priorities.
FDA lifts a partial clinical hold on Curis TakeAim Leukemia study that is intended to evaluate emavusertib in a monotherapy phase of the trial.
