Policy· August 24, 2026 · 18 min read
FDA's Expedited IND Pilot: 30-Day Safe-to-Proceed Clock and QRI Review
By Ran Chen#FDA Approval#Clinical Evidence#Pipeline
Topic
Pipeline
Clinical trial evidence, advanced-modality pipelines, development milestones, and regulatory catalysts.
Manufacturing· August 24, 2026 · 17 min read
FDA's ACTIMP Potency Guidance: Personalized Peptide and Neoantigen Lot Release
By Ran Chen#CMC#Manufacturing Capacity#Pipeline
Pipeline· August 19, 2026 · 20 min read
Avexitide LUCIDITY Phase 3: What the First GLP-1 Antagonist Means for PBH Access
By Ran Chen#Pipeline#GLP-1#Clinical Evidence
Pipeline· August 19, 2026 · 16 min read
INTerpath-001 Phase 3: Intismeran Autogene and Keytruda's Post-2028 Strategy
By Ran Chen#Pipeline#Clinical Evidence#Pivotal Trials
Pricing & Access· August 13, 2026 · 20 min read
Epilepsy Treatment Access (2026): From $0.02 Generics to Zorevunersen
By Ran Chen#Antiepileptic Drugs#Antisense#Rare Disease
Pipeline· July 30, 2026 · 19 min read
Companion Diagnostics (2026): FDA PMA Supplement Expansion & Device Landscape
By Ran Chen#Companion Diagnostic#FDA Approval#Oncology
Pipeline· July 28, 2026 · 25 min read
Psychedelic Therapy Pipeline (2026): Lilly's $3.8B AtaiBeckley Bet & Trial Registry Data
Pipeline· July 27, 2026 · 19 min read
Genome Editing Therapy Clinical Trials by the Numbers (2026)
By Ran Chen#Clinical Trials#Gene Editing#CRISPR