source
- FDA issues final guidance on potency assurance for cell and gene therapy manufacturersThe FDA released final guidance today outlining a science- and risk-based Potency Assurance Strategy for cellular and gene therapy (CGT) products. The guidance replaces the agency’s 2011 potency t…
- InventisBio's Phase 3 Trial Shows Nomelcitinib Achieves Over 70% PASI-90 Response in Chinese Psoriasis PatientsInventisBio, a Shanghai‑based biotech, completed a phase 3 study of its TYK2 inhibitor nomelcitinib in 391 Chinese patients with moderate to severe psoriasis. Participants were randomized to receiv…