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...

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...

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.

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

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...

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...

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...

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...

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....

Studies on GLP-1 drugs, specialty therapies and more help improve affordability in health care Click on the poster image to view the full-size version. Validation of Long-term Savings from a...

Read more about Prime’s leading research and insights Real-World 2-Year Clinical Outcomes Following Initiation of Glucagon-Like Peptide-1 Agonists to Treat Obesity Without Diabetes Among a...

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

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May 1, 2024 Obesity is a global epidemic and major public health issue that has grown in prevalence over recent decades in adults, adolescents and children. This Clinical Insights white paper...

PUBLICATIONS FDA Decisions Expected: February 2025 Drug pipeline for February 2025 Your monthly synopsis of new drugs expected to hit the market At Prime Therapeutics (Prime), we have positioned...

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...

Kresladi, by Rocket Pharmaceuticals, is undergoing it’s second review by the FDA for the treatment of severe leukocyte adhesion deficiency type 1 (LAD-1). In June 2024, the FDA issued a CRL for...