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Latest From Laura Helbling
One of the hallmarks of the “breakthrough” era has been the rapid expansion of first-in-human trials into pivotal studies for efficacy submissions. In a new draft guidance, FDA offers some initial thoughts on safeguards to make hyperfast development pathways successful.
US FDA encouraging developers to embrace cross-labeling rather than continue separate development of proprietary PD-1 agents, but agency sounds eager for any other good ideas to pare back the number of checkpoint inhibitors in development.
Interchangeability Comments From Biosimilar Sponsors Highlight Need For Flexibility, Challenges Of Postmarket Data Collection
In a Pink Sheet podcast, Prevision Policy analysts discuss the US Medicare program's new technology add-on payment process.