Astellas Initiates Phase 3 Study of ASP2138 in CLDN18.2-Positive Gastric Cancer
Astellas initiates Phase 3 study of ASP2138, a bispecific T-cell engager, combined with chemotherapy and pembrolizumab in CLDN18.2-positive gastric...
FDA Approves IMAAVY (Nipocalimab) for Warm Autoimmune Hemolytic Anemia
FDA approves IMAAVY for warm autoimmune hemolytic anemia after Phase 2/3 trial showed three times higher durable hemoglobin response...
Dronabinol for PTSD Nightmares Is Promising, and the Dual Diagnosis Question Changes Everything
A Nature Medicine RCT shows dronabinol cuts PTSD nightmares. For the 46% of PTSD patients who also carry a...
What Merck and SCRI’s Community Network Deal Actually Means for Site Operations
Merck and SCRI's Accelero™ collaboration targets community oncology enrollment, but the real test is whether 200+ sites can execute...
Psilocybin Works in the Lab. Can It Survive the Clinic?
A UK NHS psilocybin trial exposes the standardization gap threatening psychedelic drug approval — therapist training, setting protocols, and...
What the KRYSTAL-12 Lancet Correspondence Actually Says About PRO Reporting in KRASG12C Trials
KRYSTAL-12's EQ-5D-5L scores looked similar between arms despite heavier GI toxicity with adagrasib, a gap in PRO depth that...
The Epigenetic Clock Is Ticking — But the FDA Hasn’t Set It Yet
No epigenetic aging clock has FDA surrogate endpoint status. Here's the mechanistic gap blocking longevity drug trials—and what sponsors...
AI Antibody Design Just Got Its First Honest Report Card — And the Grade Is Complicated
A blinded 29-org benchmark in Nature Biotechnology tested 511 AI-designed antibodies against experimental data. No single algorithm won. Here's...
Sunshine Guojian Posts 95% Profit Growth With Two NMPA Drug Approvals
Sunshine Guojian posts 95% profit growth driven by two NMPA drug approvals for psoriasis and gouty arthritis in 2026.
FDA Approves Implantica’s RefluxStop for GERD Treatment
FDA approves Implantica's RefluxStop for GERD treatment based on five-year European data showing 90% improvement in symptom scores and...