FDA on CrossGov.com

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

Sun, 11 Oct 2026 00:00:00 +0000

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 agency around it has been in constant motion. The FDA has no confirmed commissioner. Marty Makary, confirmed in March 2025, resigned on 12 May 2026. Kyle Diamantas has been acting commissioner since. The President’s nominee, Heidi Overton, had her Senate HELP committee hearing on 24 September and is waiting for a vote.

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

Sun, 11 Oct 2026 00:00:00 +0000

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 confirmed the deadline: from 15 January 2027 the dye can’t be used in food sold in the US. Ingested drugs have until January 2028.

The FDA revoked Red No. 3 in January 2025 under the Delaney Clause, which bars additives shown to cause cancer in animals. It’s the only petroleum dye removal so far backed by a binding federal rule.

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

Sun, 04 Oct 2026 00:00:00 +0000

By 30 November the Centers for Medicare & Medicaid Services must publish the negotiated prices for the third group of drugs under the Medicare drug price negotiation programme. For the first time the list includes drugs given in doctors’ offices, covered by Medicare Part B: Botox, Entyvio, Orencia, Xolair and Cimzia among them. The 15 drugs cost Medicare $27 billion over twelve months to October 2025. The new prices take effect in 2028.

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

Wed, 30 Sep 2026 00:00:00 +0000

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 months. The speed came from a Commissioner’s National Priority Voucher, a programme launched in June 2025 that promises reviews in one to two months for drugs the agency judges to serve national priorities. Two of the first nine vouchers went to products made in the US.