Managing Editor, US Regulatory Analysis
Latest From Bridget Silverman
CDC’s universal recommendation for XBB COVID vaccines means that Novavax’s protein-based vaccine can enter the market immediately upon FDA authorization, but some final questions from the agency are keeping the review going.
FDA approval was swiftly followed by CDC advisory committee recommendation of the XBB.1.5. variant-based vaccines for all people aged 6 months and older.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Agency clarifies expectations for non-interventional studies providing RWD to support regulatory decisions while continuing to emphasize familiar themes around early interaction and stringent data practices.
Twelve applications with September goal dates include six novel agents but only one breakthrough designation.
Pink Sheet analysis finds big jump in the share of novel approvals that received PDUFA extensions, largely driven by clinical and safety data submissions.