Biogen’s diranersen shows 26% slowing of cognitive decline in early Alzheimer’s
Biogen's diranersen slows cognitive decline in early Alzheimer's by 26% in Phase 2 trial, matching approved amyloid therapies with...
Kelun-Biotech’s sac-TMT Plus Pembrolizumab Hits Primary Endpoint in PD-L1-Negative NSCLC
Kelun-Biotech's sac-TMT Plus Pembrolizumab hits primary endpoint in PD-L1-negative NSCLC, showing statistically significant progression-free survival improvemen
FDA Grants Priority Review to Roche’s Gazyva for Primary Membranous Nephropathy
FDA grants priority review to Roche's Gazyva for primary membranous nephropathy based on phase III trial showing 36.9% complete...
59% of Sites Are Losing Patients Before They Ever Screen — Here’s Where the Pipeline Actually Breaks
A new survey finds 59% of clinical trial sites lose eligible patients to process failures. Krishma Shah breaks down...
The Trial You Never Have to Run: How Simulation Is Rewriting Clinical Development Economics
Nature Reviews Drug Discovery's 2026 simulation-guided trial framework shows sponsors how digital modeling can cut sample sizes 13–23% and...
Compass Has Two Positive Phase 3 Trials. The FDA Has Final Guidance. So Why Does Psilocybin Still Feel Like a Gamble?
Compass Pathways' 39% six-month response rate and the FDA's final psychedelics guidance arrive together. The field looks ready. Look...
ILUVIEN Meets Primary Endpoints in Phase 4 Uveitis Trial at Six Months
ILUVIEN meets primary endpoints in Phase 4 uveitis trial, showing 31% reduction in retinal swelling and 3.6-letter visual acuity...
Mesoblast Completes Enrollment of 300 Patients in Rexlemestrocel-L Back Pain Trial
Mesoblast completes enrollment of 300 patients in its pivotal rexlemestrocel-L chronic low back pain trial, targeting mid-2027 data readout.
FDA Approves LEQEMBI IQLIK Subcutaneous Injection for Early Alzheimer’s
FDA approves LEQEMBI IQLIK subcutaneous injection for early Alzheimer's disease, enabling at-home self-administration without clinic infusions starting late Aug
Three Strikes, Same Deficiency: How Elevar Therapeutics Turned a Solvable Manufacturing Problem Into a Patient Crisis
Elevar Therapeutics received its third FDA CRL in two years for rivoceranib plus camrelizumab in liver cancer, each citing...