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...
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.
