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...
FDA grants fast-track designation to eFFECTOR Therapeutics for its zotatifin in combination with two other drugs as a second- or third-line treatment ...
FDA says it is evaluating possible safety issues with some plastic syringes manufactured by several firms in China.
FDA commissioner Robert Califf names agency chief scientist Namandj Bumpus as the replacement for retiring principal deputy commissioner Janet Woodcoc...
