Drug Approvals Monthly Update: February 2024 Specialty New drugs 2/16/2024 Amtagvi™ (lifileucel) The United States (U.S.) Food and Drug Administration (FDA) approved the first-in-class...

Novartis submitted an application to the FDA in 2Q 2025 for an intrathecal formulation (OAV101IT) of their one-time gene therapy onasemnogene abeparvovec (OAV101IT) for the treatment of spinal...

Annual conference gathers 2,500+ managed care leaders to discuss complex health care issues.

Identifying and managing diabetes and weight loss therapies earns AMCP platinum award

Maryam Tabatabai, PharmD, associate vice president of clinical information, shares more about how cell and gene therapies are transforming the treatment landscape, and how payers and providers can...

Home Newsroom Custom Content Publications Drug Approvals Drug Approvals Monthly Update: September 2024 1. ADvocate 1 and 2 trials: https://pubmed.ncbi.nlm.nih.gov/36920778/ 2. ADhere trial:...

Read Drug Approval Update Specialty New drugs 06/06/2024 Rytelo™ (imetelstat) The FDA approved the first-in-class oligonucleotide telomerase inhibitor, Rytelo, for the treatment of adults with low-...

Specialty New drugs 3/18/2024 Lenmeldy™ (atidarsagene autotemcel) Lenmeldy is an autologous hematopoietic stem cell-based gene therapy by Orchard Therapeutics, which was FDA approved for the...

Read Drug Approval Update Specialty New drugs 04/22/2024 Anktiva® (nogapendekin alfa inbakicept-pmln) The FDA approved Anktiva for use in combination with Bacillus Calmette-Guérin (BCG) for the...

Editor-In-Chief: Maryam Tabatabai, PharmD Executive Editor: Anna Schreck Bird, PharmD Deputy Editors: Erik Hamel, PharmD; Olivia Pane, PharmD, CDCES A retrospective propensity score-matched cohort...

Drug Approvals Monthly Update: August 2024 This monthly update of United States (U.S.) Food and Drug Administration (FDA) approvals provides a review of newly approved specialty drugs, new...

Clinical deep dive Disease state overview SMA is a rare, debilitating, hereditary disease characterized by progressive motor function decline and muscular atrophy. Most commonly, SMA results from a...

Zolgensma, which was FDA approved in May 2019, is administered as an intravenous (IV) infusion, with dosing based on patient weight, in pediatric patients under 2 years of age with SMA caused by...

Generic Name Brand Name Manufacturer Indication(s) Route of Administration Month Approved* aprocitentan Tryvio® Idosia Difficult-to-control or resistant hypertension Oral March budesonide Eohilia™...

Editorial team The American College of Physicians (ACP) has released a clinical practice guideline on use of pharmacological treatment for prevention of episodic migraine, defined as one to 14...

Pipeline (late-stage development) Name Manufacturer Route of administration Mechanism of action Proposed / studied indication Status Tividenofusp alfa (DNL310) AstraZeneca IV a fusion protein ERT...

Critical updates in an ever-changing environment.

Critical updates in an ever-changing environment

Shortage Updates Eli Lilly’s tirzepatide (Zepbound) is reported as currently available in all strengths, as is the T2DM formulation of tirzepatide (Mounjaro). Additionally, all strengths of Novo...

Generic Name Brand Name Brand Manufacturer Indication Approval Month* chikungunya vaccine, live Ixchiq® Valneva Austria Prevention of disease caused by Chikungunya virus November meningococcal...