FDA commissioner Marty Makary suggests more data could be required for Covid-19 vaccine boosters this winter.
A poll from the Harvard University T.H. Chan School of Public Health finds that more Americans say they will be trusting public health agencies less i...
Skadden attorneys say the FDA reduction in force should have the greatest negative impact on products that are in development.
In a wide-ranging Inside Medicine Substack interview, FDA commissioner Martin Makary says there will be no broad reorganization at the agency, althoug...
Senator Josh Hawley (R-Mo.) urges FDA commissioner Marty Makary to review a new study allegedly revealing greater safety risks than the agency current...
FDA warns Marietta, GA-based Cosco International about CGMP violations in its production of unapproved and misbranded drugs.
A group of bipartisan House lawmakers introduce the No Handouts for Drug Advertisements Act, a bill that would prohibit tax deductions for the annual ...
FDA misses a 4/29 user fee review action extension on a Stealth BioTherapeutics NDA for elamipretide, a first-in-class mitochondria-targeted therapeut...
