Biotech's digital twin rush is outpacing regulatory frameworks. Without standardized qualification, sponsors risk building trial strategies on unvalidated…
Lecanemab subcutaneous autoinjector achieves bioequivalent exposure to IV form with 104% ratio, supporting fixed-dose initiation without weight adjustments.
Denecimig demonstrates consistent safety and efficacy across age groups in hemophilia A trial, with 89% of children achieving zero...
A 46-patient LAG-3/PD-1 phase 1 trial in recurrent GBM reveals the protocol innovations sponsors need before scaling immunotherapy in...
FDA made a single pivotal trial its default approval standard on Feb. 19, 2026. Here's what clinical ops leaders...
A Bayesian PET re-analysis finds ketamine and ECT both upregulate 5-HT1B receptors, pointing to a shared biomarker that TRD...
INmune Bio's XPro demonstrates statistically significant changes in white matter and gray matter microstructure at 24 weeks in early...
Fate Therapeutics receives FDA clearance for FT839 autoimmune CAR-T therapy, a dual-targeted allogeneic cell product designed to treat rheumatoid...
Nature Medicine's RWE trial emulation framework is reshaping FDA approval pathways. Here's what sponsors running traditional RCTs need to...
SAT-3247 showed muscle fat reduction in DMD adults at six months, with participants displaying improved upper limb function and...
