A leadership vacuum at the FDA hits crisis mode as the Trump administration scrambles to replace departing senior officials and restore stability.
CBER
The regulator is allowing the pharma giant’s revised biologics licensed application to proceed to review.
The FDA issued an extremely rare refuse-to-file letter related to Moderna's new mRNA flu vaccine.
Enforcement
Premium
FDA issues warning letters to four companies for sale of HIV self-collection blood tests
The federal regulator contends the four biologics firms lack appropriate testing and marketing authorization.