FDA Unveils Long-Awaited Biosimilar Guidance to Accelerate Approvals and Cut Costs

FDA; biosimilar guidance; 2025 draft guidance; comparative efficacy study; analytical assessment; four-letter suffix; naming convention; biosimilarity; drug costs; biologic medicines

Comparative Efficacy of J&J’s Erleada and Astellas/Pfizer’s Xtandi in Non-Metastatic Prostate Cancer: Real-World Study Insights

Prostate Cancer, Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC), Erleada (Apalutamide), Xtandi (Enzalutamide), Real-World Study, Comparative Efficacy, Safety Profiles