Regulatory NewsBREAK: CMS Issues Final Negotiated Prices for Initial Price Applicability Year 2026
On Aug. 15, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the Final Negotiated Prices for Initial Price Applicability Year 2026 under the Inflation Reduction Act (IRA). The drugs selected for this negotiation are Januvia, Fiasp, Farxiga, Enbrel, Jardiance, Stelara, Xarelto, Eliquis, Entresto, and Embruvica. Access the Regulatory NewsBREAK to learn more.
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On December 9, 2025, the Food and Drug Administration (FDA) released final guidance on promotional labeling and advertising for prescription biological reference products, biosimilar products, and interchangeable biosimilar products (Final Guidance).
On December 4 and 5, 2025, the Advisory Committee on Immunization Practices (ACIP) met to discuss and vote on the committee’s recommendations for the hepatitis B birth dose and the childhood and adolescent vaccination schedule.
On November 25, 2025, the Centers for Medicare & Medicaid Services (CMS) released the maximum fair price (MFP) for each of the 15 selected drugs for IPAY 2027, which will go into effect beginning January 1, 2027. These negotiated prices reflect a marked increase in savings compared to the initial 2026 cohort, influenced by newer drugs and expanded pricing benchmarks.
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