The U.S. FDA device center’s guidance agenda for fiscal 2026 is the classic case of something old and something new, but what was borrowed from FY 2025 may make some blue.

The U.S. FDA has approved the priority sNDA for a new first-line maintenance therapy in extensive-stage small-cell lung cancer from Jazz Pharmaceuticals plc. Zepzelca (lurbinectedin) can now be combined with Tecentriq (atezolizumab, Roche AG) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Roche) as a maintenance therapy for adults who haven’t progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.

The U.K. Medicines and Healthcare Products Regulatory Agency has decided to lean into personalized medicine with the adoption of the concept of a “preference zone” for determining when a therapy can and cannot be used for a specific patient, a concept that is liable to lead to more demanding postmarket surveillance.

While the discussions and votes at the past two meetings of the U.S. CDC Advisory Committee for Immunization Practices (ACIP) have generated a lot of controversy and resulted in some states and medical groups issuing their own vaccine schedules, the truth is that the newly reconstituted committee’s recommendations to date are still in line with, or more generous in some instances than, global norms.

AI seems to suggest that a world of problems with health care spending may become more manageable, but Stephen Bittinger, a shareholder in the D.C. office of the law firm of Polsinelli PC told BioWorld that all the headaches surrounding validation of these algorithms suggests a need for an independent AI validation institute.

The market for colorectal cancer screening tests seems poised to heat up considerably with a recent request for Medicare coverage for Genoscopy’s Colosense test, but some who commented on the proposal have misgivings about the lower level of specificity seen in the Colosense relative to the Cologuard.

Caught between the start of fiscal 2026 and a congressional funding standoff that shut down much of the U.S. federal government Oct. 1, the FDA will not be able to collect 2026 user fees until Congress agrees on a continuing resolution or a 2026 appropriations bill.

A U.S. FDA complete response letter (CRL) citing manufacturing concerns has stepped into the way of a rare genetic disorder treatment. Fortress Biotech Inc. and its subsidiary, Cyprium Therapeutics Inc., said the letter in response to the NDA for CUTX-101, an injectable formulation of copper histidinate, noted cGMP deficiencies at the facility where the Menkes disease treatment is manufactured.

Patients with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment now have a new oral treatment option, with the U.S. FDA’s approval of Novartis AG’s Rhapsido (remibrutinib), a Bruton’s tyrosine kinase inhibitor administered by pill twice daily.