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FDA

FDA Grants Full Approval to Jaypirca for Relapsed CLL/SLL After Covalent BTK Therapy

The decision rests on phase 3 data showing a progression-free survival advantage over standard regimens.

FDA Approves Durvalumab Added to Perioperative FLOT for Resectable Gastric and GEJ Cancer

FDA Approves Novartis’ Itvisma for SMA Patients Ages 2 and Up

FDA Adds Boxed Liver Warning and Limits Elevidys to Ambulatory Boys 4 and Up

FDA Names Richard Pazdur to Lead Drug Review Center

FDA Rejects Biohaven’s Vyglxia for Spinocerebellar Ataxia

FDA Approves Libtayo as First Immunotherapy for Adjuvant Treatment of High‑Risk CSCC

Perioperative Nivolumab Preserves Quality of Life in Resectable NSCLC, WCLC 2025 Data Show

Vinay Prasad Resigns as FDA Biologics Director After Politicized Tenure

Sotatercept cuts risk of death and hospitalization by 76% in advanced pulmonary arterial hypertension