Keeping Track Of Approvals: US FDA Keeps Up Fast Pace In Oncology With Early Nods For Trodelvy, Pemazyre
The latest US FDA product approval news from the Pink Sheet FDA Performance Tracker.
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Latest Oncology Center of Excellence initiative is officially a CME effort designed to encourage practitioners to make full use of the information in the approved drug labeling. It is also a surprisingly effective way to explain drug approvals in a flattering light for regulators and sponsors.
The sponsors of up to seven new drugs or vaccines will find out this week whether their products will soon be approved in the EU. The products include two vaccines from Sanofi and what is possibly the first generic rival to Bayer's Xarelto to be assessed by the European Medicines Agency.
Biotech hopes this initial approval will be followed by approvals of Pemazyre in bladder cancer, first-line cholangiocarcinoma and possibly even a tumor-agnostic indication for FGFR-mutated cancers.