FDA revises an Eli Lilly emergency use authorization (EUA) for bamlanivimab and etesevimab to be used in younger pediatric patients than previously au...
FDA acting commissioner Janet Woodcock plans to play a senior role at the agency if FDA commissioner nominee Robert Califf is confirmed by the Senate.
A Yale and Harvard opinion piece says Congress should use the upcoming Cures 2.0 bill draft and the reauthorization of the medical device user fee pro...
FDA launches a new Web page about the safety of paclitaxel-coated balloons and paclitaxel-eluting stents that are approved to treat obstructed lesions...
Attorney Phil Goldberg says the New Jersey Supreme Court should decide in two pelvic mesh liability cases that juries should hear evidence of FDAs act...
FDA updates consumers on its efforts to make more prescription drug information available to pregnant and breastfeeding women.
PhRMA says it appreciates the FDA approach in a draft guidance on investigator responsibility for safety reporting for investigational drugs and devic...
The Justice Department says a self-employed medical device sales rep has agreed to pay $100,000 to resolve allegations he assisted in causing the subm...