The FDA has granted Priority Review to dersimelagon for EPP and XLP, setting a PDUFA date for late February 2027 as LEO Pharma completes its acquisition from Tanabe Pharma.
News|Articles|August 6, 2026
3 Hematology Headlines You Missed in July 2026
Author(s)Alex Hillenbrand
Fact checked by: Chelsie Derman
Hematology in July 2026: FDA priority review for Agios' mitapivat in sickle cell disease, plus Orca-T's approval for GVHD-free survival.
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The approval, backed by FINE-ONE data showing a 28% UACR reduction at 6 months, is the first new CKD treatment for this group in 3 decades.
New ASH guidelines recommend higher ferritin thresholds to improve the diagnosis of iron deficiency across key populations.
Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss Beta Bionics' new insulin patch pump, expected to be commercialized in Q1 2027.
FDA accepts Cogent's bezuclastinib NDA for advanced systemic mastocytosis, backed by APEX trial data showing durable, high-rate responses.
Ameluz is now the first FDA-approved photodynamic therapy for a skin cancer, expanding use to superficial basal cell carcinoma (sBCC) in adults.
Phase 3 data show zasocitinib use led to clear or almost clear skin in around 70% of patients by Week 16, setting up an FDA decision in early 2027.
Beta Bionics plans to launch Mint through the pharmacy channel in the first quarter of 2027.
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