The Trial Architecture Neurodegenerative Disease Has Always Needed — And Kept Refusing to Build
MAMS platform trials could end neurology's 99.6% drug failure rate. The Lancet just made the case. Here's what the...
Psychedelic Trials Are Effectively Open-Label. The FDA Has to Decide What to Do With That.
A meta-analysis of 112 psychedelic RCTs found >90% unblinding rates, meaning every efficacy estimate in the field may be...
Decentralized Trials Are Everywhere. Nobody Agrees What They’re For.
DCTs promise faster enrollment and broader diversity, but sponsors, CROs, sites, and regulators each want something different—and the TELEPIK...
FDA’s May 2026 Leadership Exodus: What the Simultaneous CDER and CBER Vacancies Mean for Sponsor IND Strategy
With Makary out May 12 and acting CDER chief Høeg fired May 15, sponsors with pending NDAs and INDs...
Pediatric Oncology Keeps Getting Treated as an Afterthought. The Biology Disagrees.
Children with cancer wait 6.5 years longer than adults to access new drugs. Adaptive and tumor-agnostic designs can close...
Neurodegenerative Drug Development Has a 2% Success Rate. Platform Trials Are the Only Honest Response.
With 51% of Alzheimer's disease-modifying compounds failing Phase III, The Lancet's case for MAMS platform trials in neurology isn't...
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...