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.

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...

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...

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...

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)...

Proposed indications Non-muscle invasive bladder cancer (NMIBC) FDA approval timeline March to May 2026 Standard Review Place in therapy Sasanlimab is a humanized immunoglobulin G4 (IgG4)...

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...