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FDA

FDA Under an Acting Commissioner: Six CDER Chiefs in Two Years, 46 Novel Approvals in 2026 and PDUFA VIII Out for Comment

On 9 October 2026 the FDA approved Hovilpri, an antiviral, as its 46th novel drug of the year. That already matches all of 2025, when the agency’s drug centre approved 46 new drugs, down from 50 in 2024. By that measure, the FDA’s core work is holding up. The …

FDA

FDA's Red No. 3 Ban Takes Effect January 15, 2027, but the Wider Food Dye Phase-Out Is Still Voluntary

On 5 August the FDA rejected the last legal objection to its ban on Red No. 3, a petroleum-based dye used in candy and baked goods. That …

budget

Medicare's First Negotiated Part B Drug Prices Are Due November 30 as the MFN Pricing Model Shrinks From $11.9 Billion to $440 Million in Savings

By 30 November the Centers for Medicare & Medicaid Services must publish the negotiated prices for the third group of drugs under the …

FDA

FDA Becomes a Tool of Industrial Policy: Priority Vouchers, PreCheck and the 100% Pharma Tariff That Most Big Drugmakers Avoid

On 1 April 2026 the FDA approved Eli Lilly’s Foundayo, an obesity pill, 50 days after the company filed. Standard reviews take about ten …