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...
Rybrevant’s Second Act: How J&J Is Rewriting the Rules for EGFR-Mutant Lung Cancer
From exon 20 insertions to subcutaneous delivery and inclusive trial design, Joshua Bauml explains why the biology demanded a...
Another AI Clinical Data Platform Just Launched. Here’s What Sponsors Actually Need to Ask Before They Sign.
nPhase's AI clinical data platform promises smarter trial design, but before sponsors add another vendor, the activation-cycle math deserves...
MRI Surveillance Alone Outperforms MRI Plus Radiation in SCLC Trial
MRI surveillance alone reduced cognitive failure risk by 40% versus MRI plus radiation in SCLC patients, per phase III...
Trastuzumab Botidotin Shows 11.1-Month PFS vs T-DM1 in Phase 3 Trial
Trastuzumab Botidotin Phase 3 trial shows 11.1-month PFS versus 4.4 months with T-DM1 in HER2-positive breast cancer, with manageable...