US FDA’s Fastest Approvals Concentrate In Oncology, Infectious Disease
The agency’s quickest approvals include two in 2020 – Gilead’s Veklury and Seattle Genetics’ Tukysa – but two 1990s AIDS drugs are at the top of the list.
You may also be interested in...
Pandemic Perspectives: Veklury’s Clinical Development Timeline Compressed By Collaborative Review, Previous Research
Just five and half years elapsed between Gilead’s first remdesivir IND for Ebola virus and Veklury’s US FDA approval for COVID-19.
FDA’s oncology review team likes to do things its own way – and at its own hyper fast pace.
With strong data from Moderna and Pfizer, the projection for an EUA by the end of 2020 still may hold despite holidays and other obstacles to completing the necessary work.