TSC-101 Achieves Complete Donor Chimerism in 93% of AML Patients in Phase 1
TSC-101 achieves complete donor chimerism in 93% of AML patients in Phase 1, with manufacturing success rate at 90%...
Nature Medicine’s June 2026 Benchmark Study Reveals General-Purpose LLMs Outperform FDA-Cleared Clinical AI — and Exposes a Validation Gap Regulators Have Not Closed
A Nature Medicine study finds GPT-5.2, Gemini 3.1 Pro, and Claude Opus 4.6 outperform FDA-cleared clinical AI tools on...
Atsena’s ATSN-201 Gene Therapy Enrolls Rapidly in Phase 3 Trial for X-Linked Retinoschisis
ATSN-201 gene therapy enrolls 10% of its 76-patient Phase 3 trial within weeks, targeting BLA filing in late 2028...
Boehringer Ingelheim launches three Phase III trials for obrixtamig and zongertinib
Boehringer Ingelheim launches three Phase III trials for obrixtamig and zongertinib across neuroendocrine carcinoma and HER2-mutant NSCLC.
Regeneron’s Cemdisiran Accepted for FDA Review in Generalized Myasthenia Gravis
Regeneron's cemdisiran accepted for FDA review in generalized myasthenia gravis, targeting November 2026 action date via Priority Review Voucher.
FDA Grants Breakthrough Therapy Designation to Elsunersen for SCN2A Epilepsy
FDA grants Breakthrough Therapy Designation to elsunersen for SCN2A epilepsy, based on 77% sham-adjusted seizure reduction in Phase 1/2...
Why AI Readiness Starts with the Digital Foundation
AOP Health's VP of Digital on why platform consolidation has to come before the AI conversation
The FDA’s Bayesian Guidance Arrives at Your Site Whether You’re Ready or Not
FDA's January 2026 Bayesian statistics draft guidance reshapes protocol design, interim analysis workflows, and site staffing budgets—here's what operators…
The Specialized Clinical AI Trap: General-Purpose Chatbots Are Winning the Benchmark War
A Nature Medicine study shows general-purpose LLMs outperform specialized clinical AI tools on real physician questions—exposing a validation crisis...
MoonLake’s Sonelokimab Achieves 67% HiSCR75 Response in Phase 3 HS Trial
MoonLake's sonelokimab Phase 3 HS trial shows 67% of adults achieved HiSCR75 response at one year, with a third...