Keeping Track: Tecentriq, Opdivo Approvals Intensify Spotlight On Immuno-Oncology
The latest drug development news and highlights from our FDA Performance Tracker.
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FDA’s most recent accelerated approvals for Merck’s Keytruda call for confirmatory trials in a broader patient population than the approved indications, in the latest example of FDA’s growing comfort with multi-purpose confirmatory trials in the PD-1/PD-L1 inhibitor space.
Modeling can better inform candidate and dose selection, and support novel endpoints, labeling and postmarketing safety, even though it means stepping off the beaten path for drug development, participants say at US FDA's inaugural workshop on model-informed drug development under PDUFA VI.
Novo’s long-acting coagulation Factor IX showed polyethylene glycol (PEG) accumulation in the choroid plexus of animals, potentially raising a neurological safety issue when used in humans, FDA says ahead of Blood Products Advisory Committee review.