This monthly approval update provides a review of newly approved specialty drugs, recent drug launches, generic updates, new indications and news of note on drugs in the approval process.

Tab 1 BEHAVIORAL HEALTH CORNER WEIGHT MANAGEMENT CORNER Clinical News EDITOR-IN-CHIEF: Maryam Tabatabai, PharmD EXECUTIVE EDITOR: Anna Schreck Bird, PharmD DEPUTY EDITORS: Erik Hamel, PharmD;...

The content in this publication is not a substitute for professional medical advice. For questions regarding any medical condition or if you need medical advice, please contact your health care...

Understanding your data INO-3107 is a DNA immunotherapy composed of a plasmid encoding for antigens from both HPV-6 and HPV-11 as well as a plasmid encoding for an interleukin-12 (IL-12) immune...

Gene therapy harnesses the body’s capacity to heal itself

WEIGHT MANAGEMENT CORNER The American Heart Association (AHA) has published a Presidential Advisory forecasting the extent of cardiovascular disease (CVD) and stroke expected in the U.S. through...

SAVINGS PER CASE $11,500 An employer group with 7,000 lives implemented HighTouchRx. They saw savings of $194,300, with HighTouchRx providing an ROI of 5:1.4 Since its launch, HighTouchRx has saved...

PUBLICATIONS FDA Decisions Expected: January 2026 Your monthly synopsis of new drugs expected to hit the market All brand names are property of their respective owners. References SERENA-6 trial:...

The American Gastroenterological Association (AGA) has released a clinical practice guideline on management of gastroparesis, including recommendations for diagnosis and effective treatment (e.g.,...

Clemidsogene lanparvovec (RGX-121) is an investigational, one-time intracisternal adeno-associated virus serotype 9 (AAV9) gene therapy delivering the iduronate-2-sulfatase (IDS) gene directly to...

From next-gen CFTR modulators to gene therapy and real-world drug impact, cystic fibrosis care is constantly evolving. Maryam Tabatabai, PharmD, of Prime Therapeutics, explains how innovative...

Managed Healthcare Executive: Prior authorization using integrated medical claims data helps diabetes patients get medications faster, with two-thirds processed automatically by July 2025 in this...

The CDC is reporting influenza-like illness (ILI) for the week ending March 15, 2025 (week 11). Seasonal influenza activity remains increased across the U.S. but has decreased for five consecutive...

Prime Therapeutics Report shares more about single-treatment gene therapies and proper management

Jan. 26, 2026 – folic acid oral solution (Quiofic) 505(b)(2) NDA approval; other formulations of folic acid include the following: oral capsule, oral tablet, solution for injection and an OTC oral...

Annual meeting will feature industry research posters and educational sessions

Oct. 29, 2025 – denosumab-desu (Jubereq) BLA approval; the 120 mg/1.7 mL single-dose vial for SC use has received FDA approval as an interchangeable biosimilar to the same presentation of denosumab...

New biosimilars Feb. 26, 2026 – zongertinib (Hernexeos) Boehringer Ingelheim; kinase inhibitor; Accelerated Approval, Assessment Aid, Breakthrough Therapy, Commissioner's National Priority Voucher...

publications Spring 2024 Prime Therapeutics Report March 15, 2024 The Prime Therapeutics Report is your source for innovative managed care strategies, trends and updates. Our cover story (Page 6)...

The information provided has been developed based on available information as of March 3, 2025. This therapy is NOT FDA approved, and content may change as more information becomes available....

December 17, 2024 PUBLICATIONS FDA Decisions Expected Drug pipeline for January 2025 Your monthly synopsis of new drugs expected to hit the market At Prime Therapeutics (Prime), we have positioned...

References Abeona Therapeutics announces FDA accepts and grants Priority Review for Pz-cel biologics license application (BLA). November 27, 2023. Available at:...

Prime study finds the cost of GLP-1s continues to be a significant driver of total cost of care, which remained $4,490 higher in Year 3 compared to a matched control group

Your monthly synopsis of new drugs expected to hit the market At Prime Therapeutics (Prime), we have positioned ourselves to best prepare our clients to manage new drugs. Our clinical and trade...

Drug information happenings publications Trending Topics & Drug Approvals: June 2026 Your source for the latest drug information highlights May 15, 2026 — baxdrostat (Baxfendy) NDA approval;...

PTC Therapeutics is awaiting the FDA decision for ataluren for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). The FDA granted ataluren Fast Track and Orphan Drug...

publications What 2025 Revealed About the Future of Oncology Care January 14, 2026 Author: Simone Ndujiuba, PharmD, BCOP Over the past year, Oncology Insights highlighted the oncology topics...

References Annual review of factor replacement products. Oklahoma Health Care Authority Review Board. Updated April 2016. https://oklahoma.gov/ohca.html. Accessed April 1, 2022. Burke T, Asghar S,...

Merck submitted a combination product containing pembrolizumab and berahyaluronidase alfa as a subcutaneous (SC) version of pembrolizumab (Keytruda) for approval across all previously approved...

Plozasiran, by Arrowhead, is a first-in-class RNA interference (RNAi) therapeutic designed to reduce production of apolipoprotein C-III (APOC3), thereby reducing circulating triglycerides (TG). It...

A paragraph is a self-contained unit of a discourse in writing dealing with a particular point or idea. Paragraphs are usually an expected part of formal writing, used to organize longer prose. Tap...

Merck submitted clesrovimab to the FDA for respiratory syncytial virus (RSV) disease prevention in infants during their first RSV season. If approved, clesrovimab will be the third monoclonal...

publications High Cost Therapy Profile: November 2024 Zenocutuzumab Intravenous (IV) Oncology Proposed indications Pancreatic ductal adenocarcinoma (PDAC) and non–small cell lung cancer (NSCLC)...

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...

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...

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...

With an established playbook for launching new union business, we ensure smooth transitions, clear communication and rapid implementation. Our Special Investigations Unit (SIU) uses advanced...

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...

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...

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,...