US FDA Oncology Applications: Real-Time Review And Breakthrough Pathway Show Durable Appeal
Recent submissions include what could be the fourth novel agent approved under the RTOR pilot.
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Keeping Track: New Nucala Indication; BMS’ Ide-Cel Clears Filing Hurdle; First Applications From Telix And ADC Therapeutics
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Seattle Genetics holds the award for fastest supplemental approval (11 days) and fastest new molecular entity approval (119 days) under the US FDA's RTOR program, according to the Pink Sheet's Performance Tracker.
Acquisition is based on the prospects for Immunomedics’ Trodelvy, but regulatory changes, manufacturing challenges, and research dynamics could upset even the best-laid plans.