Approvals· July 3, 2026 · 17 min read
Topic
Accelerated Approval
Surrogate endpoints, confirmatory trials, withdrawal risk, payer skepticism, and commercial exposure.
Approvals· June 11, 2026 · 10 min read
FDA Commissioner's National Priority Voucher program: what launch teams need to know
Pipeline· June 5, 2026 · 11 min read
Atacicept PDUFA preview: first dual BAFF/APRIL therapy approaches IgA nephropathy decision
By Ran Chen#PDUFA Date#FDA Approval#Clinical Evidence
Approvals· May 28, 2026 · 7 min read
Beqalzi coverage guide: sonrotoclax access in mantle cell lymphoma
Policy· May 22, 2026 · 10 min read
Postmarketing requirement tracker for accelerated-approval products after launch
Pipeline· May 7, 2026 · 4 min read