News

The CRL was given because the FDA did not consider the phase 1/2 IGNYTE trial to be an adequate and well-controlled clinical ...
In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...
The FDA has decided not to approve vusolimogene oderparepvec (RP1) in combination with nivolumab for advanced melanoma.
A 55-year-old man’s swollen toes and fingers turned out to have a much stranger explanation than expected. In a recent case ...