Approvals· September 5, 2026 · 29 min readEtcamah's Sept 4 Approval Does Not Rewrite Orserdu PAs or ODAC's ctDNA DisputeFDA granted accelerated approval to camizestrant (Etcamah) on Sept 4, 2026. We analyze SERENA-6 PFS, ODAC's 3-6 vote, live...By Ran Chen#FDA Approval#NDA Approval#Accelerated Approval
Policy· August 30, 2026 · 17 min readFDA Licensed XFG COVID Vaccines: Part B Differs from ACIP and ACA 2713FDA licensed four 2026-2027 XFG COVID vaccines under CBER supplements. We analyze letter PMCs versus stale Medicare.gov copy, and Part...By Ran Chen#Infectious Disease#Coverage Access#Medicare Part B
Policy· July 29, 2026 · 25 min readFDA 503A Wellness-Peptide Vote (July 2026): Six Peptides and the Bulk-List ProcessA decision-grade analysis of the FDA PCAC July 23-24 2026 votes recommending six wellness peptides for the Section 503A Bulk Drug...By Ran Chen#FDA Advisory Committee#Payer Policy#Drug Pricing