An FDA Advisory Committee votes 16 to 1 that Pfizers Paxlovid (nirmatrelvir and ritonavir) has a favorable benefit-risk profile for treating mild-to-m...
FDA commissioner Robert Califf calls on health insurers to play a role in seeing that confirmatory trials are completed for drugs approved through the...
FDA publishes a draft guidance on using electronic systems, records, and signatures in clinical investigations of some regulated products.
FDA modifies a partial clinical hold against Stoke Therapeutics to allow the administration of a higher single dose of STK-001 (70 mg) in its ongoing ...
Federal Register notice: FDA seeks comments on an information collection extension entitled Radioactive Drug Research Committees 21 CFR 361.1.
Federal Register notice: FDA withdraws approval of six ANDAs from multiple applicants after they notified the agency that the products are no longer m...
Sens. Paul and Hassan reintroduce their bill to require FDA to more clearly identify differences between generic drugs that have been submitted for ap...
The Department of Justice says former drug sales representative Vincent Tornari pled guilty to one count of healthcare fraud and wire fraud involving ...
