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 January 15, 2026, the White House released its Great Healthcare Plan (the Plan) as a broad framework for congressional action on lowering drug prices, lowering insurance premiums, and increasing price transparency. The Plan outlines several policy ideas for Congress to consider.
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.
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