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.
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A new analysis from BIO, Informa Pharma Intelligence and QLS looks at clinical drug development activity from the past decade, looking at the most (and least) successful areas. Infographic depicts key trends and details.
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.
US FDA Revisits Gonorrhea Drug Development As Fast-Emerging Resistance, Preclinical Challenges Hold Back New Products
From animal models to non-inferiority margins, US FDA is seeking new perspectives on gonorrhea R&D, including how to incorporate extragenital infections into clinical programs.