The Priority Review

Clinical trials

Eli Lilly and Company, Boehringer Ingelheim, and IgA Nephropathy: the issue of September 28, 2026

The week of September 28 to October 4, 2026: 29 briefs, 3 stories, led by Eli Lilly and Company, Boehringer Ingelheim, and IgA Nephropathy.

By The Priority Review desk

Compiled by code from the week's stream briefs and stories linked below; no model wrote this page. How we use automation

The week of September 28 to October 4, 2026 on The Priority Review: 29 briefs and 3 stories, led by Eli Lilly and Company, Boehringer Ingelheim, and IgA Nephropathy. Every line links its page.

Stories this week

Approvals briefs

  • 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.

Clinical trials briefs

11 more briefs in Clinical trials.

Regulation briefs

  • PRAC carries out safety assessment duties at its 28 September - 1 October meeting. The Pharmacovigilance Risk Assessment Committee (PRAC) reviewed 9 safety signals, 85 periodic safety update reports, 49 risk management plans and 16 post-authorisation safety studies. No referral procedures were started, ongoing or concluded during the meeting. Source: Source record, October 2, 2026.
  • EMA sets end-of-year submission dates for type I variations in 2026. EMA advises marketing authorisation holders to submit type IA annual updates, individual type IA and type IA IN variations, and super-groupings no later than 20 November 2026. Submissions received after 20 November will still be processed, but the outcome may not be issued until January 2027. Source: Source record, October 1, 2026.
  • EMA Management Board highlights September 2026 meeting. The EMA Management Board reviewed its mid-year report and progress on new pharmaceutical legislation during the September 2026 meeting. It noted 29 new human medicine applications, seven veterinary applications, and that the Clinical Trials Information System has supported more than 14,000 trials with over 200 new applications each month. Source: Source record, October 1, 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.
  • EMA endorses ICMRA joint statement on animal testing alternatives. EMA has endorsed a joint statement from the International Coalition of Medicines Regulatory Authorities (ICMRA) calling on medicine developers, manufacturers, regulators and national control laboratories to advance alternative methods to animal testing throughout the medicine lifecycle. The statement sets a long-term goal of replacing animal testing at all stages, from initial candidate screening to post-authorisation activities. Source: Source record, October 1, 2026.

2 more briefs in Regulation.

Policy briefs

  • CMS announces $90 MEDICARE Part B premium rebate for 20.8 million beneficiaries. CMS announced a $90 MEDICARE Improvement Fund Premium Rebate for eligible MEDICARE Part B beneficiaries, with most receiving a direct deposit around October 8, 2026. The rebate is available to 20.8 million Americans in Original MEDICARE Part B who are not receiving Medicaid premium assistance or paying an Income-Related Monthly Adjustment Amount. Source: Source record, October 3, 2026.
  • CMS convenes certified IDR leaders to discuss federal program improvements. CMS Administrator Dr. Mehmet Oz and officials from the Departments of Health and Human Services, Labor, and the Treasury met with representatives from all certified IDR entities on October 1, 2026. The meeting addressed the increasingly high IDR-associated costs affecting the United States healthcare system and the move of the Federal IDR Portal into the IDR Gateway, which will launch in late 2026. Source: Source record, October 2, 2026.
  • CMS highlights Texas employers' use of CHOICE Arrangement. CMS, SBA and Take Command showcased how Texas businesses are adopting the CHOICE Arrangement to give employees tax-advantaged contributions toward individual health coverage. The model offers employers predictability and employees more choice, according to the press release. Source: Source record, September 30, 2026.

How this issue is made

Code builds this page every Monday from the week's published briefs and stories, listed above. The three topics in the title are the names the briefs tag most often that week. No model writes this page.