CDER says it is seeking to withdraw unresolved citizen petitions that have lingered for more than five years at the agency without producing formal re...
Eitan Medical recalls its Sapphire MT Infusion Pump, Sapphire Epidural Infusion Pump, and Sapphire Plus Infusion Pump due to software issues.
Federal Register notice: FDA sends to OMB an information collection extension entitled Orphan Drugs 21 CFR Part 316.
Based on high discontinuation rates in a just-reported clinical trial, Pfizer says it will not advance its twice-daily weight-loss drug danuglipron in...
FDA grants Genmab a breakthrough therapy designation for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneous...
Becton Dickinsons Carefusion unit recalls (Class 1) its Alaris Infusion Pumps due to compatibility issues with Cardinal Health Monoject syringes.
Federal Register notice: FDA sends to OMB an information collection extension for the registration of human drug compounding outsourcing facilities.
Federal Register notice: In separate rulemakings, FDA proposes to classify into Class 3 certain types of wound dressings and liquid wound washes conta...
