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...

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

The Minnesota-based pharmacy benefit manager says a program that resulted in patients switching from two incretin therapy prescriptions to one yielded $7,500 in savings per patient and a total of...

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:...

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...

BioPharma Dive: There are no drugs specifically for polycystic ovary syndrome, a chronic condition that can cause infertility. One study is testing whether Wegovy might be beneficial.

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...

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...

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;...

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

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...

Cover image for The evolution of GLP-1s Developing a holistic, individualized strategy to capitalize on opportunities and outcomes Prime Therapeutics /the-evolution-of-glp-1s About Prime...

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....

New report explores traditional, specialty therapy trend impact to employers

Gene therapy harnesses the body’s capacity to heal itself

Prior authorization using integrated medical claims data helps diabetes patients get medications faster, with two-thirds processed automatically by July 2025 in this Prime Therapeutics analysis

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)...

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

Prime Therapeutics research shows that persistence with GLP-1 weight-loss therapies continues to improve, offering new insights into long-term treatment trends and outcomes

cover image for Summer 2025 Issue: Clinical Insights – MASH A new era in liver health: Treatment innovation, payer strategy, and pipeline momentum Prime Therapeutics...

Editorial team nisoldipine (Sular) Drug Approvals July 31, 2026 — rituximab-cdxx (Zimrixby) BLA approval; 100 mg/10 mL (10 mg/mL) injection in a single-dose vial for IV use and 500 mg/50 mL (10...

Report encourages providers to consider health contexts and lifestyle modifications as well as personal preferences and current guidelines when prescribing GLP-1s for weight loss

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,...

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...

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...

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...

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...

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

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

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...

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...

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

None Trending Topics New drugs July 11, 2025 – finerenone (Kerendia) Bayer; non-steroidal mineralocorticoid receptor antagonist (MRA); first MRA FDA-approved for heart failure (HF) with left...

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.

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...

Prime’s industry-leading research on GLP-1s was recognized at the Academy of Managed Care Pharmacy (AMCP) Annual Meeting in Houston

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...

New or expanded indications Trending Topics Glossary The AAP released its recommendations for the prevention and management of influenza during the 2026–2027 season. Annual influenza vaccination...

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...

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...

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

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...

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...

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...

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,...

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...

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...

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...