FDA actions, week of September 28, 2026: 1 approval, 1 rule, 3 notices
The FDA published 5 actions in the week of September 28 to October 4, 2026: 1 approval announcement, 1 final rule in the Federal Register and 3 notices in the Federal Register.
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Approvals
- FDA approves pirtobrutinib for previously untreated CLL or SLL. The FDA approved pirtobrutinib (Jaypirca, Eli Lilly and Company) on October 2, 2026 for adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma with no known 17p deletion. The approval follows the BRUIN CLL-313 trial, which enrolled 282 patients and showed a median progression-free survival that was not estimable versus 33.5 months for bendamustine plus rituximab. Source: FDA approval page, October 2, 2026.
Final rules
- FDA classifies flushing and storage solution for vascular autografts at room temperature as class II. The order places the device type into class II (special controls), which the FDA has determined will provide a reasonable assurance of the safety and effectiveness of the device. The FDA said the action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens. Source: Federal Register rule, September 30, 2026.
Notices
- FDA determines ISTURISA not withdrawn from sale. The FDA has determined that ISTURISA (osilodrostat) tablets, 10 mg, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications for osilodrostat tablets, 10 mg if all other legal and regulatory requirements are met. Source: Federal Register notice, September 30, 2026.
- FDA requests nominations for consumer representatives on advisory committees. The FDA is requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and panels for which vacancies currently exist or are expected to occur in the near future. Nominations will be accepted for current vacancies and for those that will or may occur through December 31, 2026, with interest letters due by November 16, 2026. Source: Federal Register notice, October 1, 2026.
- FDA requests nominations for voting members of advisory committees. The agency is seeking qualified individuals to fill scientific, technical, professional, and other voting-member positions. The notice was published October 1, 2026. Source: Federal Register notice, October 1, 2026.
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