One Cancer Case Is All It Takes: Why Gene Therapy’s Post-Market Safety Infrastructure Is Still Broken
A rare gene therapy-linked cancer case exposes the gap between FDA's 15-year CAR-T surveillance mandate and real-world monitoring systems...
The CHMP’s May 2026 Output Signals a Structural Shift in European Drug Development — Sponsors Should Take Notes Now
EMA's CHMP recommended 8 new medicines and 13 indication extensions in May 2026—including camizestrant for ESR1+ breast cancer and...
Intellia’s CRISPR Submission Is a Regulatory Stress Test the FDA Has Never Faced Before
Intellia's nex-z BLA for ATTR amyloidosis is the FDA's first in vivo CRISPR reckoning—and the agency's gene therapy playbook...
The Nacubactam Trials Just Proved Something the FDA Needs to Hear About AMR Drug Development
Integral-1's Phase 3 results for cefepime–nacubactam vs. imipenem show 89% composite cure rates — and a regulatory blueprint AMR...
China Filed 3,073 IND Applications in 2024. The West Hasn’t Noticed What That Number Actually Means.
China's CDE accepted 3,073 IND applications in 2024, up from 70 in 2015. For global trial sponsors, that seismic...
One Colonoscopy, Thirteen Years, and a Mortality Signal That Didn’t Arrive: What the NordICC Trial Really Breaks
The NordICC RCT cut colorectal cancer incidence but missed its mortality target — exposing a design flaw that should...
Enpatoran’s Phase 2 Miss Exposes a Protocol Design Flaw That Every SLE Sponsor Needs to Confront
Enpatoran improved BICLA response rates in moderate-to-severe SLE but failed its primary dose-dependent endpoint—a design flaw sponsors can't afford...
When J&J Eliminates the Interim: What the NANORAY-312 Amendment Actually Signals
J&J's FDA-accepted protocol amendment to NANORAY-312 drops the interim analysis for NBTXR3—here's what that move reveals about pivotal trial...
Semaglutide’s Alcohol Data Is Stronger Than Anyone Expected — and the FDA Has No Playbook for It
A landmark Lancet RCT shows once-weekly semaglutide cuts alcohol use in obesity patients with AUD. The FDA's regulatory pathway...
NMN in ITP: A Phase 1/2 Signal That Should Rewrite How We Design Rare Disease Trials
A phase 1/2 NMN trial in immune thrombocytopenia just posted a clean safety signal and platelet response data that...