FDA announces a 6/18 advisory committee meeting to review Modernas controversial mRNA-based seasonal influenza vaccine.
HHS secretary Robert F. Kennedy Jr. faces renewed scrutiny from Senate Democrats for ignoring requests about the role of longtime anti-vaccine activis...
Eli Lilly reports that its investigational obesity drug retatrutide produced weight-loss results approaching those historically associated with bariat...
FDA warns Dr. Sourav Mishra about violations in his conduct of a clinical investigation at the All India Institute of Medical Sciences in Bhubaneswar,...
FDA warns Alexandria, LA-based cardiologist Naseem Jaffrani about his failure to conduct a clinical investigation according to the investigational pla...
Former FDA associate commissioner Peter Pitts says FDA has an opportunity with the resignation of commissioner Marty Makary to reset its operation and...
A Clinical Trial Vanguard post describes the issues facing FDA in determining how to review and approve a BLA for a one-time CRISPR gene edit to addre...
FDA publishes a guidance with recommendations for sponsors planning to submit food-effect studies for INDs or NDAs.
