Bridget Silverman
Managing Editor, US Regulatory Analysis
Latest From Bridget Silverman
Novavax’s ’23-’24 COVID Vaccine Can Bypass Another CDC Cmte Meeting – If FDA Authorizes It
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.
Pediatric Data Concerns Can’t Derail US CDC’s Universal ’23-’24 COVID Vaccine Recommendation
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.
Keeping Track: Rybrevant Goes RTOR, Two-Part Review For Dasiglucagon, And CRL For Ultomiris
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Real-World Data Can Include EUA Observations, US FDA Final Guidance Says
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.
A Standard September Ahead Thanks To Light US FDA User Fee Calendar With Few Expedited Reviews
Twelve applications with September goal dates include six novel agents but only one breakthrough designation.
A 3-Month Delay For A Better Label: US FDA User Fee Goal Extensions Are Usually Good News
Pink Sheet analysis finds big jump in the share of novel approvals that received PDUFA extensions, largely driven by clinical and safety data submissions.