6 Hematology Headlines You Missed in January 2026

January 2026 brought a wave of clinically meaningful updates across hematology, spanning new clinical practice guidelines, regulatory approvals, and late-stage pipeline momentum in both malignant and nonmalignant disease. Organizations including the American Society of Hematology (ASH) and Kidney Disease: Improving Global Outcomes (KDIGO) released updated guidance aimed at improving diagnostic accuracy and supportive care, while the US Food and Drug Administration (FDA) expanded treatment options for rare bleeding and thrombotic disorders.

Notable developments this month included new ASH guidelines to support earlier diagnosis of AL amyloidosis, FDA approvals expanding access to therapies for acquired fibrinogen deficiency and pediatric acquired thrombotic thrombocytopenic purpura, and the submission of a New Drug Application (NDA) for rusfertide in polycythemia vera. In addition, ASH leadership highlighted ongoing efforts to address funding facing the hematology community. Together, these updates reflect continued progress in precision diagnostics, rare disease management, and the future sustainability of hematology research and care.

Read below to catch up on the 6 hematology headlines you missed in January 2026.

Expert Perspective

ASH Addresses Funding, Career Development Gaps in Hematology, With President Robert Negrin, MD

HCPLive spoke with Robert Negrin, MD, the newly elected president of ASH, about the society’s initiatives to sustain hematology research, support early-career development, and address global challenges in clinical hematology.

Related: Looking Ahead to ASH’s 68th Meeting, With President Robert Negrin, MD

New Guidelines

KDIGO Releases New Guideline for Anemia in Chronic Kidney Disease

The 2026 KDIGO guideline update for the management of anemia in chronic kidney disease expands upon the prior 2012 guidance, with updated recommendations and practice points related to iron management, red blood cell (RBC) transfusions, and emerging therapies. The guideline incorporates new evidence intended to support individualized anemia management across the spectrum of CKD care.

ASH Releases New Clinical Practice Guidelines for Diagnosing AL Amyloidosis

Published on January 28, 2026, in Blood Advances, new clinical practice guidelines from ASH outline best practices to support clinicians in recognizing and diagnosing AL amyloidosis, a disease frequently missed or diagnosed late due to its heterogeneous presentation.

The panelists recommend blood and urine testing, including serum immunofixation, urine immunofixation, and serum free light chain assays, when clinical suspicion for AL amyloidosis exists. To confirm diagnosis, the panel supports the use of surrogate biopsies through combined bone marrow biopsy and abdominal fat pad sampling in most cases, while recognizing that target organ biopsies may be appropriate in select clinical scenarios.

FDA Updates

FDA Approves Caplacizuman-yhdp (Cavlivi) as First Pediatric aTTP Therapy

On January 5, 2026, the FDA approved caplacizumab-yhdp (Cablivi; Sanofi) for injection to treat pediatric patients aged ≥12 years with acquired thrombotic thrombocytopenic purpura, in combination with plasma exchange and immunosuppressive therapy. The decision builds upon caplacizumab’s initial 2019 approval for adults with aTTP.

The approval was supported by efficacy data from a retrospective chart review of 30 patients aged 2–18 years, in which 80% achieved clinical remission. Notably, the decision makes caplacizumab the first FDA-approved therapy for pediatric aTTP.

FDA Approves 2-Gram Presentation of Fibryga for Acquired Fibrinogen Deficiency

On January 7, 2026, the FDA approved a 2-gram presentation of fibrinogen (human) lyophilized powder for reconstitution (Fibryga) for fibrinogen replacement in patients with acquired fibrinogen deficiency. Fibryga is the first and only virus-inactivated, human plasma–derived fibrinogen concentrate approved for this indication in the US.

Takeda and Protagonist Announce Submission of Rusfertide NDA for Polycythemia Vera

Takeda and Protagonist Therapeutics announced the submission of a new drug application to the FDA for rusfertide to treat adult patients with polycythemia vera. The submission is based on a positive 32-week primary analysis and 52-week results from VERIFY, a phase 3 study evaluating rusfertide in combination with standard of care. The ongoing trial will follow patients for up to 124 weeks.