Amgen's Blincyto Adds Pediatric Claim For Leukemia
Study supporting accelerated approval for the leukemia drug satisfied an FDA written request under the Best Pharmaceuticals for Children Act.
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Sponsors of established products like Amgen's Kyprolis and Blincyto and Bristol's Sprycel work to bulk up labeling with new indications while FDA reviews at least six novel agents for blood cancers.
Amgen is the leader in approved bispecific antibodies and oncolytic viruses, but the company's not shy about expanding its oncology pipeline with even more modes of delivering medicines to cancer patients.
Keeping Track: Sandoz Erelzi Is Third Biosimilar To Clear FDA; Expanded Labels For Arzerra, Blincyto
The latest drug development news and highlights from our FDA Performance Tracker.