The Priority Review

Clinical trials

Abbott, COPD, and AbbVie: the issue of October 26, 2026

The week of October 26 to November 1, 2026: 47 briefs, 7 stories, led by Abbott, COPD, and AbbVie.

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

In this story: Contents

The week of October 26 to November 1, 2026 on The Priority Review: 47 briefs and 7 stories, led by Abbott, COPD, and AbbVie. Every line links its page.

Stories this week

Terms this week

  • Pharmacometric modeling – a type of mathematical analysis. In this approval, the FDA said it showed that blood levels of Awiqli in pediatric patients become similar to blood levels in adults after the first few doses. (FDA: approval notice for Awiqli in pediatric patients)
  • Project Orbis – an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among international partners. (FDA: approval notice for talazoparib with enzalutamide)
  • Dialysis – a treatment that filters the blood to rid the body of harmful wastes, extra salt and water. (MedlinePlus: Dialysis)
  • Accelerated approval – a pathway that allows earlier approval of drugs that treat serious conditions and fill an unmet medical need. (FDA: Accelerated Approval Program)

Approvals briefs

  • FDA approves first plasmid DNA-based immunotherapy for adults with RRP. The FDA granted accelerated approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for adults with recurrent respiratory papillomatosis, a rare disease caused by HPV. In an open-label multicenter trial of 32 adults, 27% of patients who had at least three baseline surgeries did not require any surgery during the first year after treatment. Source: FDA approval page, October 30, 2026.
  • FDA approves talazoparib with enzalutamide for metastatic prostate cancer. On October 26, 2026, the FDA approved talazoparib (Talzenna, Pfizer Inc.) in combination with enzalutamide for adults with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer with homologous recombination repair gene mutations, as detected by an FDA-authorized test. The TALAPRO-3 trial showed median radiographic progression-free survival not reached (95% CI: NR, NR) versus 45.8 months (95% CI: 37.7, NR) with a hazard ratio of 0.48 [95% CI: 0.36, 0.65]; p<0.0001. Source: FDA approval page, October 26, 2026.

Clinical trials briefs

  • Abbott reports strong 30-day outcomes in TECTONIC IVL study. The TECTONIC CAD IVL IDE Study enrolled 335 patients and met its primary safety endpoint with a 30-day target lesion failure rate of 0.3%. The study also achieved a primary effectiveness endpoint with procedural success in 97% of patients. Source: Source record, November 1, 2026.
  • Hoffmann-La Roche posts results of Phase III crovalimab study in aHUS. Results for the Phase III, single-arm study of crovalimab in adult and adolescent patients with atypical hemolytic uremic syndrome were first posted on ClinicalTrials.gov on October 30, 2026, after enrolling 83 participants. The study, which began on October 22, 2021, reached primary completion on October 9, 2025. Source: Source record, October 30, 2026.
  • Boehringer Ingelheim registers Phase III trial of verducatib in COPD. The AIRWARD Study plans to enroll 1800 participants with COPD and plans to start on March 10, 2027. It evaluates whether verducatib reduces flare-ups and improves lung function compared with placebo over up to 1.5 years. Source: Source record, October 30, 2026.
  • Abbott initiates CROWN-MV pivotal trial for Cephea device. Abbott has started the CROWN-MV study, a prospective pivotal trial that will enroll up to 585 patients with symptomatic mitral valve disease in the U.S., Canada and Europe. The trial will evaluate the safety and effectiveness of the investigational Cephea Mitral Valve System, a catheter-based replacement option for patients not candidates for surgery or transcatheter repair. Source: Source record, October 29, 2026.
  • Boehringer Ingelheim posts results of 1-yr Tiotropium/Salmeterol study in COPD. Results for the 220-participant, Phase 3, randomized, triple-masked study were posted on October 29, 2026. The study compared FDC tiotropium/salmeterol with single agents and assessed FEV1, dyspnoea, health status and exacerbations. Source: Source record, October 29, 2026.
  • Alexion posts results of Phase 3 ARTEMIS ravulizumab trial. The company posted results for its Phase 3 ARTEMIS study, which enrolled 555 participants and was terminated after primary completion on October 7, 2025. The trial assessed a single dose of ravulizumab IV versus placebo in adult participants with CKD undergoing non-emergent cardiac surgery with cardiopulmonary bypass. Source: Source record, October 29, 2026.

22 more briefs in Clinical trials.

Regulation briefs

  • CMS final rule clarifies oversight of Organ Procurement Organizations. The Centers for Medicare & Medicaid Services published a final rule that clarifies recertification, competition, and appeals processes for Organ Procurement Organizations. The rule defines unsound medical practices and requires OPOs to have QAPI programs to monitor adverse events. Source: Source record, October 30, 2026.
  • FDA releases revised draft guidance on drug delivery device performance. The FDA announced the availability of a revised draft guidance published October 30, 2026. The guidance replaces the draft guidance announced July 1, 2024 and provides recommendations for development and organization of device drug-delivery performance information. Source: Federal Register notice, October 30, 2026.
  • FDA classifies radiology software for fibrotic lung disease as class II. The FDA finalized an order classifying the radiology software for referral of findings related to fibrotic lung disease as class II with special controls that will be part of the codified language for classification. The agency said the classification provides reasonable assurance of safety and effectiveness and may enhance patients' access to beneficial innovative devices by reducing regulatory burdens. Source: Federal Register rule, October 30, 2026.
  • PRAC starts review of Deanxit and human normal immunoglobulin safety signal. PRAC has begun a review of Deanxit, a fixed-dose combination for depression and anxiety, after reports of serious neurological and psychiatric side effects. PRAC also started a review of a safety signal concerning increased reporting of hypersensitivity reactions associated with specific batches of human normal immunoglobulin medicines, including Flebogamma DIF, Yimmugo and Gamunex that have been withdrawn. Source: Source record, October 30, 2026.
  • CMS finalizes 2027 ESRD PPS rule with $297.52 base rate. On Oct. 28, 2026, CMS issued a final rule that sets the 2027 ESRD PPS base rate at $297.52, an increase of $15.81 from the 2026 rate, and projects a 2.7% rise in total payments to about 7,600 facilities. The rule also updates phosphate binder inclusion, low-volume and pediatric payment adjustments, and the home and self-dialysis training add-on payment. Source: Source record, October 28, 2026.
  • FDA releases draft guidance on electronic IDE submission template. Comments on the draft guidance are due by December 28, 2026. The guidance targets sponsors filing IDE applications with the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research. Source: Federal Register notice, October 28, 2026.

5 more briefs in Regulation.

Policy briefs

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.