FDA clears ImmunityBio’s Anktiva expansion in bladder cancer after regulatory whiplash
Following a bumpy regulatory road that involved a refusal-to-file, ImmunityBio has won FDA approval to expand Anktiva into papillary-only non-muscle-invasive bladder cancer (NMIBC). Wednesday’s approval comes nearly three months ahead…
US FDA approves Novartis’ gene therapy for rare muscle disorder
The U.S. Food and Drug Administration has approved Novartis’ gene therapy for patients with a rare muscle disorder, the drugmaker said on Monday. The therapy, branded as Itvisma, was approved…
Lupin receives US FDA approval for its generic cancer drug
Indian pharma major Lupin announced that the US Food and Drug Administration has approved its abbreviated new drug application for Lenalidomide capsules in strengths of 2.5 mg to 25 mg…
