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, showing 31% reduction in retinal swelling and 3.6-letter visual acuity...
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 disease, enabling at-home self-administration without clinic infusions starting late Aug
Elevar Therapeutics received its third FDA CRL in two years for rivoceranib plus camrelizumab in liver cancer, each citing...
The 2024 McDonald MS criteria raised diagnosis rates 28% and cut median time to diagnosis from 84 to 40...
The FDA's July 2026 psychedelic guidance is nonbinding on paper. In practice it tells psilocybin, LSD, and MDMA developers...
Caidya and Simbec-Orion's merger creates a 6-month operational danger zone for sites running active studies. Here's what sponsor clinops...
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.
