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.

train fast run on railway track in sunny day

The recent, and quite rapid, approval of Gilead Sciences, Inc.’s Veklury (remdesivir) highlights the agency’s willingness to prioritize therapies for emerging infectious disease threats.

Veklury cleared the agency on 22 October 2020, just 77 days after NDA submission for treatment of COVID-19 requiring hospitalization....