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FDA Approval

FDA Fast-Tracks Augmentin XR in First Approval Under National Priority Voucher Pilot

The two-month review showcases an onshoring-focused pathway intended to strengthen antibiotic supply resilience.

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

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

FDA Approves Epkinly Monotherapy and Triplet Regimen for Relapsed Follicular Lymphoma

FDA Approves Lurbinectedin Plus Atezolizumab for First-Line Maintenance in Extensive-Stage SCLC

FDA Grants Accelerated Approval to Forzinity, First Therapy for Barth Syndrome

FDA Approves Ionis’ Dawnzera to Prevent Hereditary Angioedema Attacks

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