Category: Hematology
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Novo Nordisk’s denecimig cuts bleeding in hemophilia A regardless of inhibitors
Phase III trial shows once‑monthly and once‑weekly denecimig (Mim8) significantly reduces annualized bleeding rate versus standard care, with up to 95% of patients bleed‑free.
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ASH25: Gallop’s LYT-200 shows unprecedented survival in AML
The company’s execs talk about the striking efficacy and safety signals seen in Phase I data, the science behind the molecule, and their vision for transforming AML therapy.
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Secura Bio’s Copiktra PTCL data shines at ASH 2025
The company’s exec talks about how new analyses bolster the case for Copiktra in tough-to-treat lymphomas, informing a pivotal Phase III trial strategy.
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Sanofi’s ASH 2025: Redefining rare blood disorder care
Sanofi’s head of rare diseases, Jeff Schaffnit, outlines the company’s dual approach: redefining hemophilia care and pioneering immune modulation for rare blood disorders.
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ASH25: Tessera’s gene writing hits curative thresholds in sickle cell
New preclinical data show Gene Writing tech exceeding key efficacy benchmarks for sickle cell disease and in vivo CAR-T generation.
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FDA expands Grifols’ antithrombin therapy in children
The US regulator approves expanded Thrombate III label, offering new treatment options for children with hereditary antithrombin deficiency.
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Grifols expands US diagnostic manufacturing with new San Diego facility
The company plans to open a high-tech San Diego plant to boost US blood typing production, meeting rising transfusion demand.
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Limula and IPC partner to advance stem cell transplant processing
Swiss biotech Limula teams with Institut Paoli-Calmettes to automate stem cell processing and improve patient care.
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Global study probes blood-based approach to blood disorder diagnosis
A 1,500-patient study will evaluate single-cell RNA sequencing as a less invasive alternative to bone marrow biopsies.
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FDA clears Sanofi’s Wayrilz as first for rare blood disorder
The US regulatory agency approves Sanofi’s Wayrilz as the first BTK inhibitor for treating persistent or chronic immune thrombocytopenia.
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Santersus wins second FDA Breakthrough Device nod for NucleoCapture
FDA granted the Swiss company’s blood purification technology Breakthrough Device status for severe lupus, marking its second designation.
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Faron gains FDA support for registrational trial in HR-MDS
Following the news of the US FDA endorsement and the finalized Phase II/III trial design, the company’s stock rose by over 7%.
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Navigating the Risks and Rewards of Biomarker-Based Surrogates and Accelerated Approval
The risks and rewards of biomarker-based surrogates are crucial for optimizing clinical trial outcomes and guiding effective treatments.
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ASH25: Gallop’s LYT-200 shows unprecedented survival in AML
The company’s execs talk about the striking efficacy and safety signals seen in Phase I data, the science behind the molecule, and their vision for transforming AML therapy.
-
Promis reports first human evidence of aβ oligomer reduction by pmn310
PMN310 demonstrates dose-dependent reduction of amyloid-beta oligomers in human CSF, marking a key milestone in Alzheimer’s treatment development.
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Urologic Health secures $11 million for non-invasive bladder monitoring
Urologic Health raises $11million seed funding to advance a catheter-free bladder monitoring platform toward FDA clearance and US market entry.
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Novo Nordisk’s denecimig cuts bleeding in hemophilia A regardless of inhibitors
Phase III trial shows once‑monthly and once‑weekly denecimig (Mim8) significantly reduces annualized bleeding rate versus standard care, with up to 95% of patients bleed‑free.