Keeping Track: Submissions Complete For Breakthrough Therapies From Portola And Catalyst; FDA Finally Approves Bridion, Basaglar
The latest drug development news and highlights from our FDA Performance Tracker.
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If approved, Zolyd will be the first intravenous epoxide antibiotic approved in the US, with greater potency than the oral version used first-line. Ex-US, the I.V. formulation has demonstrated a stable resistance profile.
Even in the grip of the pandemic, review times for priority drugs were also consistent with the last three years.
Influence of expedited review pathways and regulatory incentives is on display in 2020’s novel approvals, which have a composition reassuringly consistent with recent years.