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FDA publishes a draft guidance with information for sponsors who are developing certain local anesthetic drug products to produce postoperative analge...
FDA publishes a draft guidance on using electronic systems, records, and signatures in clinical investigations of some regulated products.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 ...
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 ...
An FDA advisory committee briefing document says data support the efficacy of Pfizers Paxlovid (nirmatrelvir and ritonavir) for treating mild-to-moder...
