Keeping Track: A Glut Of Big Approvals While Lartruvo Makes Its Market Exit
The latest drug development news and highlights from our US FDA Performance Tracker.
You may also be interested in...
Bausch gets an untitled letter from the US FDA criticizing a video and webpage promoting its psoriasis lotion. The agency also objects to superiority efficacy claims based on post hoc analyses of a single phase II trial after expressing similar concerns to the company two years ago.
Innovative trial designs and biostatistics can make pediatric drug development more efficient, but strategies like extrapolating adult data using bridging biomarkers or Bayesian analyses have complex data requirements that demand coordination and forethought.
Amivas requested a US tropical disease PRV for intravenous artesunate but FDA has not yet made a decision on eligibility; approval appears to block La Jolla’s competing product, currently under review, for seven years.