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
Approvals· September 4, 2026 · 36 min readLirafugratinib's Sept 27 PDUFA Does Not Rewrite Pemazyre PAs or Lytgobi CDxElevar's lirafugratinib faces a Sept 27 FGFR2 CCA PDUFA. We analyze live Pemazyre and Lytgobi SPLs, FEP Blue CDx gates, and...By Ran Chen#PDUFA Date#FDA Approval#NDA Approval
Approvals· September 2, 2026 · 33 min readAqneursa's Sept 19 A-T PDUFA Does Not Rewrite NPC-Only PAs or the 15 kg FloorFDA set a Sept 19 PDUFA for Aqneursa in ataxia-telangiectasia. We evaluate IB1001-303 data, NPC SPL lag, FEP Blue's PA gate, and UHC's...By Ran Chen#PDUFA Date#FDA Approval#NDA Approval
Pricing & Access· June 6, 2026 · 12 min readUnitedHealthcare GLP-1 coverage: PA criteria, reauth rules, and plan variationsUHC covers Wegovy and Zepbound on some plans with PA. Maps PA criteria, BMI thresholds, 5% reauth weight-loss rule, CV indication...By Ran Chen#GLP-1#UnitedHealthcare#UHC