When the Scan Knows Before the Spirometer Does
Professor Peter George, Pulmonologist at the Royal Brompton and Senior Medical Director at Brainomix, on why quantitative CT is...
FDA Hears 80 Speakers on Psychedelic Drug Therapy Standards
The FDA held a public hearing on psychedelic drug therapy, drawing more than 1,800 registered attendees and 80 speakers...
Compass Pathways Just Answered the Durability Question. Now Comes the Harder Problem.
Compass Pathways' 52-week COMP360 data shows 40-45% response rates in treatment-resistant depression. FDA approval in 2027 means nothing without...
Biohaven Advanced BHV-7000 to Pivotal Trials Without Answering a Question the FDA Requires Every Sponsor to Answer
FDA's Sept. 4 partial hold on Biohaven's opakalim exposes a metabolite characterization gap that ICH M3(R2) and FDA's 2021...
The FDA Just Handed Psychedelic Drug Sponsors a Framework. Now the Hard Part Starts.
FDA finalized its psychedelic drug guidance July 14, 2026. COMPASS, Usona, and MAPS now face blinding failures, DEA barriers,...
YPrime Guide: Supply Management Critical to IRT Trial Success for Biotech Sponsors
Supply management and vendor accountability determine IRT trial success for biotech sponsors. YPrime's guide identifies critical cost exposure points...
Researchers Misread IRB Review Pathways, Delaying Study Startups
Researchers commonly misread IRB review pathways, causing study delays. Understanding exemption categories and expedited eligibility prevents protocol cycling.
Definium’s DT120 ODT Meets Primary Endpoint in Phase 3 GAD Study
Definium's DT120 ODT met its primary endpoint in Phase 3 testing for generalized anxiety disorder, potentially offering an alternative...
Sionna to Test SION-451 and SION-2222 Combo in CF Phase 2a Trial
Sionna advances SION-451 and SION-2222 into Phase 2a trial to test dual-corrector approach for Trikafta-resistant CF patients.
Ivonescimab beats pembrolizumab on survival in first-line PD-L1-positive NSCLC
Ivonescimab beats pembrolizumab on survival in first-line PD-L1-positive NSCLC, extending median OS by over eight months in Phase III...