In a quiet week for approvals from the US Food and Drug Administration, Novartis AG’s slow-growing blockbuster heart drug Entresto gained an expanded indication in heart failure.
The FDA’s popular Real-Time Oncology Review (RTOR) pilot program grew by two after Seagen Inc. and Astellas Pharma, Inc. recently submitted supplemental biologics license applications for the urothelial cancer therapy Padcev. Sesen Bio, Inc. also bid to join the bladder cancer market with a BLA for Vicineum