US FDA’s Oncology Center In The Lockdown: ‘Business As Usual’
Amid the COVID-19 pandemic, Richard Pazdur doesn’t want the cancer patient forgotten. His solution: keep churning out approvals.
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Joining the international regulatory collaboration could become a key route for the UK to remain an early and priority market for global launches after the end of the Brexit transition period, says the industry group, BIA.
FDA medical review leaders have been remarkable on balancing the two challenges of finding treatments for COVID-19 and keeping everything else running on time.
Merck’s anti-PD-1 therapy Keytruda keeps piling up new indications, including three approved by US FDA in just two weeks – all during a pandemic. The remarkable therapy has been a centerpiece for an equally remarkable period of regulatory innovation.