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.
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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.
The FDA emphasized the rigor of its review of the first COVID-19 therapy, which used few expedited pathways on its way to approval after a two-and-a-half-month review. Post-marketing studies will address remaining concerns about dosing and special populations.
Stephen Hahn also said the expedited approval process could be even more efficient.