Keeping Track: Bristol Tests US FDA’s TMB Tolerance, Celltrion Resubmits Herceptin Biosimilar, Nocdurna Approved At Last
Executive Summary
The latest drug development news and highlights from our US FDA Performance Tracker.
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Alexion Gets Speedy Review For Soliris Successor
Switching patients from the very expensive ultra rare disorder drug to ravulizumab will be a key strategy for Alexion if the latter is approved. Recent compelling data in paroxysmal nocturnal hemoglobinuria patients suggests the long-acting C5 complement inhibitor could offer more benefit than its predecessor with more convenient dosing.
Keeping Track: Keytruda Adds Two New Uses, Furoscix ‘Patch Pump’ Gets A CRL, And Nightstar Nabs An RMAT
The latest drug development news and highlights from our US FDA Performance Tracker.
Roche, Bristol On The Defensive After Merck's Lung Cancer Wins At ASCO
With Merck's Keytruda on top of the world and setting the standard for PD-1/L1 lung cancer data, Roche and Bristol defended the programs for their competing Tecentriq and Opdivo during ASCO investor events.