Copy to clipboard Copied! September 27, 2024 At Prime Therapeutics (Prime), we have positioned ourselves to best prepare our clients to manage new drugs. Our clinical and trade relations teams keep...

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...

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

Event will feature David Lassen, chief clinical officer

Clinical deep dive Disease state overview RRP is a rare condition which manifests clinically as persistent wart-like growths (papillomas) within the aerodigestive tract, primarily in the larynx,...

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...

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...

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.

Drug pipeline for July 2026 At Prime Therapeutics (Prime), we have positioned ourselves to best prepare our clients to manage new drugs. Our clinical and trade relations teams keep a keen eye on...

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...

Expert Clinical Network Insights Hemophilia Medication insights: marstacimab-hncq (Hympavzi) The U.S. Food and Drug Administration (FDA) approved marstacimab-hncq (Hympavzi) in October 2024 for...

July 2, 2026 Author: Abby Kim, PharmD, BCOP From potential new standards of care to unexpected innovations reshaping treatment paradigms, the 2026 American Society of Clinical Oncology (ASCO)...

HighTouchRx® Insert Link Learn more about biosimilars As part of our comprehensive drug management strategy, we actively promote the evidence-based use of FDA-approved biosimilars and other...

Pipeline (late-stage development) Name Manufacturer Route of administration Mechanism of action Proposed / studied indication Status Durvalumab (Imfinzi) AstraZeneca; MedImmune IV Programmed...

Proposed indications Hematological malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndromes (MDS). FDA approval timeline April 6, 2026...

Jan. 28, 2025 – hydrochlorothiazide (Inzirqo) 505(b)(2) NDA approval; Standard Review; first oral suspension formulation of hydrochlorothiazide; previously available oral solutions are no longer...

cover image for summer 2025 New therapies, payer strategies and pipeline updates shaping the future of managed care  Prime Therapeutics /summer-2025-prime-therapeutics-report The Prime Therapeutics...