Proposed indications Mucopolysaccharidosis type II (MPS II), also known as Hunter Syndrome FDA approval timeline April 5, 2026 (review extended) Breakthrough Therapy Fast Track Orphan Drug Priority...

Proposed indications Epstein-Barr virus-positive (EBV+) post-transplant lymphoproliferative disease (PTLD) United States (U.S.) Food and Drug Administration (FDA) approval timeline Jan. 15, 2025...

Traditional Jun. 28, 2024 – Ahzantive™ (aflibercept-mrbb) Formycon received FDA approval for Ahzantive™ as a biosimilar to Regeneron’s Eylea® (aflibercept). Ahzantive™ is a vascular endothelial...

Regeneron has resubmitted their fully human immunoglobulin G4 (IgG4)-based CD20 x CD3 bispecific antibody, odronextamab, to the FDA for the treatment of R/R follicular lymphoma (FL) after two or...

Pipeline (late-stage development) NAME MANUFACTURER ROUTE OF ADMINISTRATION MECHANISM OF ACTION PROPOSED/STUDIED INDICATION STATUS Aurora-GT United IV Gene therapy; autologous endothelial...

cover image for Reimagine Cancer Care: Insights That Drive Smarter Decisions Explore the latest oncology trends, payer strategies and pipeline updates shaping the future of managed care. Prime...

This monthly update of United States (U.S.) Food and Drug Administration (FDA) approvals provides a review of newly approved specialty drugs, new indications and recent first-time generic launches.

This monthly update of United States (U.S.) Food and Drug Administration (FDA) approvals provides a review of newly approved specialty drugs, new indications and recent first-time generic launches.

This monthly update of United States (U.S.) Food and Drug Administration (FDA) approvals provides a review of newly approved specialty drugs, new indications and recent first-time generic launches.

Real-World Adherence and Persistence to Glucagon-Like Peptide-1 Receptor Agonists Among Non-Diabetic Obese Commercially Insured Adults Authors: A.M. Wilson, PharmD; B.D. Hunter, MS; K....