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.

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PUBLICATIONS FDA Decisions Expected: August 2026 Your monthly synopsis of new drugs expected to hit the market July 21, 2026 Drug pipeline for August 2026 At Prime Therapeutics (Prime), we have...

AAD American Academy of Dermatology AAV adeno-associated virus ACP American College of Physicians AD atopic dermatitis AI artificial intelligence AML acute myeloid leukemia ANCA anti-neutrophil...

The FDA granted a Priority Review for zoliflodacin, a first-in-class, spiropyrimidinetrione oral antibiotic by Innoviva, for the treatment of uncomplicated gonorrhea in adults and pediatric...

June 29, 2026: oxylanthanum carbonate Veligrotug is an anti-insulin-like growth factor-1 receptor (IGF-1R) antibody developed by Viridian and submitted to the FDA for the treatment of thyroid eye...

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...

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...

Vanda Pharmaceuticals submitted the atypical antipsychotic agent milsaperidone to the FDA for the treatment of bipolar I disorder and schizophrenia. Milsaperidone is an active metabolite of Vanda’s...

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

Shortages in the manufacturing chain have led to label hopping and an increase in off-label use

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,...

In the latest episode of the “Pharmacy Friends” podcast, hear about a new clinical report from Prime Therapeutics that dives into the latest evidence-based insights related to the rising prevalence...

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...

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...

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...

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...