Hematology

NCI Trials Mirdametinib and Sirolimus in RAS Mutated Relapsed Refractory Multiple Myeloma

A clinical trial is underway to evaluate the safety and efficacy of mirdametinib and sirolimus in patients with RAS mutated relapsed refractory multiple myeloma.

Phase II Study of Elranatamab in Outpatients with Relapsed/Refractory Multiple Myeloma

The study aims to assess the incidence of cytokine release syndrome during the first treatment cycle of elranatamab in RRMM patients.

FDA Submission Update for Ruxolitinib by Apotex

Apotex has submitted New Drug Application (NDA) for Ruxolitinib under application number NDA219660.

FDA Accepts BLA761147 for PEGFILGRASTIM-PCCG by Accord Biopharma

The FDA has accepted the Biologics License Application for BLA761147, PEGFILGRASTIM product from Accord Biopharma.

Study on Familial Platelet Disease with RUNX1 Variants Launched

A longitudinal study has been initiated to investigate familial platelet disease (FPD) associated with RUNX1 variants.

Gene Therapy for Sickle Cell Disease Shows Promising Safety and Efficacy in 36 Patients

An expanded access protocol for a gene therapy targeting BCL11A in sickle cell disease has shown increased fetal hemoglobin levels without unexpected safety issues in 36 patients.

Study on Digital Support Impact on Multiple Myeloma Patient Quality of Life

A prospective study is underway to evaluate the effectiveness of a personalized web-based platform on the quality of life for multiple myeloma patients.

FDA Approves JAKAFI XR (Ruxolitinib Phosphate) Submission by Incyte

The FDA has approved the New Drug Application (NDA) for JAKAFI XR, a formulation of ruxolitinib phosphate, submitted by Incyte Corporation.

Phase 1 Study of Tomivosertib in Relapsed/Refractory AML Initiates Dose Finding

A Phase 1 trial for tomivosertib in relapsed or refractory acute myeloid leukemia is set to begin, utilizing Bayesian optimal interval dose finding design.

Efgartigimod shows potential as maintenance therapy for iTTP in pilot study

A pilot study indicates that efgartigimod may effectively increase ADAMTS13 activity in patients with iTTP, potentially preventing relapses.

Safety and Feasibility Study of CD34+ Stem Cells in RUNX1 Familial Platelet Disorder

A study is underway to assess the safety and feasibility of mobilizing and collecting autologous CD34+ hematopoietic stem cells in patients with RUNX1 familial platelet disorder.

Evaluation of LumiraDx D-Dimer Assay for VTE Diagnosis

The study assesses the accuracy of the LumiraDx D-Dimer assay in diagnosing venous thromboembolism.

Study on Predictive Factors for Thromboembolic Events in High-risk Polycythemia Vera

A prospective observational study is set to enroll 150 patients with high-risk Polycythemia Vera to identify predictive factors for thromboembolic events.

Asciminib Efficacy in Real-World CML Patients in Second-Line Treatment Assessed

An observational study is underway to evaluate the efficacy and tolerability of asciminib in real-world settings for CML patients in second or subsequent lines of treatment.

FDA Submission for Ruxolitinib by Apotex Receives Standard Review Status

Apotex has submitted New Drug Application for Ruxolitinib under NDA219660, which is currently under standard review.

FDA Approves Eltrombopag Olamine Application by Biocon Pharma

The FDA has approved the application ANDA220660 for Eltrombopag Olamine submitted by Biocon Pharma.

EUGIA PHARMA's Tranexamic Acid Supplement Receives FDA AP Status

EUGIA PHARMA's application for a supplement of Tranexamic Acid has received FDA approval status.

CCR7(low) Treg Subset Linked to Poor Prognosis in B-ALL

The study identifies a correlation between a highly suppressive CCR7(low) Treg subset and poor prognosis in B-ALL.

FDA Approves Lenalidomide Supplement by Zydus Pharmaceuticals

The FDA has approved a supplemental application for lenalidomide submitted by Zydus Pharmaceuticals.

FDA Approves Lenalidomide ANDA217554 Submission by Deva Holding AS

The FDA has approved the ANDA217554 submission for Lenalidomide by Deva Holding AS.

Study on Erythropoietin's Impact on Hepcidin Levels in Healthy Volunteers

This study aims to assess how intravenous erythropoietin affects serum and urinary hepcidin levels.

Mezagitamab Study Initiated for Chronic Primary Immune Thrombocytopenia

A clinical trial is underway to evaluate the efficacy of mezagitamab in stabilizing platelet counts in adults with chronic primary immune thrombocytopenia compared to placebo.

FDA Accepts Supplemental Application for REVLIMID by Bristol Myers Squibb

The FDA has accepted a supplemental application for REVLIMID (lenalidomide) submitted by Bristol Myers Squibb.

FDA Licenses First-Ever Freeze-Dried Plasma Product in the U.S.

The FDA has licensed Ezplaz Freeze Dried Plasma, the first of its kind in the U.S., for transfusion in adults.

Regeneron initiates study on linvoseltamab for high-risk monoclonal gammopathy

Regeneron Pharmaceuticals is conducting a proof-of-concept study to evaluate linvoseltamab's efficacy in eliminating abnormal plasma cells in patients at risk of multiple myeloma.

Cipla's Lenalidomide ANDA213165 Receives AP Status from FDA

Cipla's application for lenalidomide has received an Abbreviated Approval (AP) status from the FDA.

Novo Nordisk Initiates Post-Marketing Surveillance for Alhemo® in Haemophilia Patients

Novo Nordisk is conducting a post-marketing surveillance study on Alhemo® to assess its safety and effectiveness in real-world settings.

Long-term Outcomes of Transplantation vs Standard Care in Sickle Cell Anemia Assessed

An observational study is being conducted to reevaluate long-term cerebrovascular outcomes in sickle cell patients post-transplantation.

FDA Accepts Supplemental Application for REVLIMID by Bristol Myers Squibb

The FDA has accepted a supplemental application for REVLIMID (lenalidomide) from Bristol Myers Squibb.

Ultomiris Phase III trial fails to meet primary endpoint in HSCT-TMA

Ultomiris did not achieve statistical significance for event-free survival in HSCT-TMA patients compared to placebo.

Novartis initiates long-term safety study for ruxolitinib and panobinostat combination

Novartis is conducting a long-term safety study for patients previously treated with ruxolitinib or its combination with panobinostat.

Study on FLT3 Inhibitors' Immunological Impact Post-HSCT in AML Patients

A study is underway to evaluate the immunological effects of Gilteritinib and other FLT3 inhibitors in AML patients post-allogeneic stem cell transplantation.

FDA Accepts Supplement for RYTELO (Imetelstat Sodium) by Geron

The FDA has accepted a supplemental application for RYTELO (Imetelstat Sodium) submitted by Geron.

Merck's Bomedemstat Trial for Polycythemia Vera Aims to Improve Treatment Outcomes

Merck is conducting a clinical trial to evaluate the efficacy of bomedemstat compared to standard treatments for polycythemia vera.

Isatuximab Evaluated in Stem Cell Transplant for Multiple Myeloma and Lymphoma

A clinical trial is investigating the effects of Isatuximab on the immune system during stem cell recovery in multiple myeloma and lymphoma patients.

Lenalidomide being studied for treatment of adult histiocyte disorders

A clinical trial is investigating Lenalidomide for treating Langerhans cell histiocytosis, Erdheim-Chester disease, and histiocytic sarcoma.

NCI Launches Study on Myelodysplastic Syndromes to Enhance Treatment Options

The National Cancer Institute is conducting a comprehensive study on the natural history of MDS and MDS/MPN, aiming to collect biological samples for better treatment development.

Blood Sampling Study for Sickle Cell Disease Research Initiated by NIDDK

A study has been launched to collect blood samples from individuals with unique red blood cell features related to sickle cell disease.

Study on 18F-Fluciclovine PET/CT for Improved Detection in Multiple Myeloma

A clinical trial is underway to evaluate the efficacy of 18F-fluciclovine PET/CT compared to 18F-FDG in detecting multiple myeloma.

Long-Term Study of DISC-1459 for EPP Shows Safety and Efficacy Potential

The study is designed to evaluate the safety, tolerability, and efficacy of DISC-1459 in patients with EPP.

AstraZeneca Initiates Phase 1b/2 Trial of AZD0120 for Relapsed/Refractory Multiple Myeloma

AstraZeneca is conducting Phase 1b/2 trial of AZD0120, a dual CAR T-cell therapy targeting CD19 and BCMA, in patients with relapsed/refractory multiple myeloma.

FDA Accepts Supplemental NDA for VONJO (Pacritinib Citrate)

The FDA has accepted a supplemental NDA for VONJO, JAK inhibitor, indicating progress in its regulatory pathway.

FDA Accepts Supplement for JAKAFI (Ruxolitinib Phosphate) by Incyte

The FDA has accepted a supplemental application for JAKAFI, JAK inhibitor developed by Incyte.

FDA Approves Supplemental Application for INREBIC (Fedratinib Hydrochloride)

The FDA has approved a supplemental application for INREBIC, a treatment for myelofibrosis.

FDA Grants Approval for Ferric Carboxymaltose by Mylan

The FDA has granted approval for Ferric Carboxymaltose under application ANDA217769 submitted by Mylan.

FDA Grants Approval for Ferric Carboxymaltose by Mylan Labs

The FDA has granted approval for Ferric Carboxymaltose under application ANDA212572 submitted by Mylan Labs.

FDA Approves Ferric Carboxymaltose for Mylan's ANDA217076

The FDA has approved Mylan's application for Ferric Carboxymaltose under ANDA217076.

FDA Accepts Supplemental Application for NEUPOGEN by Amgen

The FDA has accepted a supplemental application for NEUPOGEN (filgrastim) from Amgen, indicating ongoing development.

Agios initiates trial of mitapivat in pediatric PKD patients with no transfusion history

Agios Pharmaceuticals is conducting a trial to assess mitapivat's efficacy and safety in pediatric patients with PKD who are not regularly transfused.

FDA Approves Supplemental Application for PURIXAN by Nova Labs

The FDA has approved a supplemental application for PURIXAN, an antimetabolite containing mercaptopurine, submitted by Nova Labs.

FDA Grants Priority Review for Novartis' Fabhalta (Ipacopan Hydrochloride)

The FDA has granted priority review status for Novartis' NDA for Fabhalta, containing ipacopan hydrochloride.

Study on Engineered Dendritic Cell Vaccines for Multiple Myeloma Initiated

A clinical trial is underway to assess the feasibility, safety, and efficacy of engineered dendritic cell vaccines for multiple myeloma.

Study on C1q-Binding HLA Antibodies and Platelet Transfusion Response

A clinical trial is investigating the effectiveness of C1q-binding HLA antibodies in predicting platelet transfusion responses in thrombocytopenic patients.

JNJ-79635322 Dose Escalation Study in Multiple Myeloma Shows Promising Combinations

The study aims to establish recommended Phase 2 doses for JNJ-79635322 in combination with daratumumab and other agents.

CAR-T Cell Therapy for ALL: Emerging Research Trends and Focus Areas Identified

A bibliometric analysis reveals a significant growth in CAR-T cell therapy research for acute lymphoblastic leukemia, with a focus on long-term outcomes and risk assessment.

FDA Grants Approval for Amneal's Phytonadione ANDA217734

The FDA has granted approval for Amneal's Abbreviated New Drug Application for Phytonadione.

Faron Pharmaceuticals Initiates Phase IIb Trial of Bexmarilimab in Higher-risk Myelodysplastic Syndromes

Faron Pharmaceuticals is conducting Phase IIb trial (BEXERA) to evaluate bexmarilimab combined with azacitidine in treatment-naïve higher-risk MDS patients.

Phase 1 Trial of VAS-101 Gel for Improved Curcumin Absorption in Sickle Cell Disease

A clinical trial is underway to evaluate the efficacy of VAS-101, a skin gel containing curcumin, in patients with stable sickle cell disease.

Lilly to acquire Ajax Therapeutics for myelofibrosis and polycythemia vera

Lilly is acquiring Ajax Therapeutics to enhance its portfolio in treating myelofibrosis and polycythemia vera, leveraging Ajax's lead program, AJ1-11095, a first-in-class Type II JAK2 inhibitor.

FDA Accepts Supplement for FERAHEME by AZURITY

The FDA has accepted a supplemental application for FERAHEME, an iron replacement therapy.

FDA Grants AP Status for Dr. Reddy's PHYTONADIONE ANDA215820

The FDA has granted Abbreviated Approval (AP) status for Dr. Reddy's ANDA215820 for PHYTONADIONE.

AstraZeneca's AZD0120 Phase I Study in Multiple Myeloma Initiated

AstraZeneca has initiated Phase I study to evaluate the safety and tolerability of AZD0120 in multiple myeloma patients.

Teva's Eltrombopag Olamine ANDA209938 Receives Approval

Teva Pharmaceuticals has received approval for their ANDA209938 application for Eltrombopag Olamine.

Ionis Pharmaceuticals Evaluates Sapablursen in Polycythemia Vera Patients

Ionis Pharmaceuticals is conducting a study to assess the efficacy of sapablursen in reducing phlebotomy frequency and improving quality of life in polycythemia vera patients.

FDA Approves JAKAFI XR for Incyte Corp.

The FDA has approved JAKAFI XR, a formulation of ruxolitinib phosphate, for use.

Phase II Trial of Nemtabrutinib with CAR T-cell Therapy in Relapsed/Refractory CLL/SLL

A phase II trial is investigating the efficacy of combining nemtabrutinib with lisocabtagene maraleucel in patients with relapsed/refractory CLL/SLL.

Phase II Study of Allogeneic Stem Cell Transplant for VEXAS Syndrome Initiated

A Phase II clinical trial is underway to evaluate the efficacy of allogeneic hematopoietic stem cell transplant in patients with VEXAS Syndrome.

FDA Approves Isatuximab-irfc Subcutaneous Injection for Multiple Myeloma

The FDA has approved isatuximab-irfc for subcutaneous administration in multiple myeloma.

Natural History Study of MBL and CLL/SLL to Identify Disease Progression Markers

A natural history study is being conducted to investigate the clinical and molecular aspects of MBL, CLL/SLL, and related lymphomas.

Novartis initiates tolerability study of ianalumab with TPO-RA in ITP patients

A new study is assessing the tolerability of ianalumab combined with investigator's choice TPO-RA in ITP patients.

Elranatamab shows robust efficacy and favorable safety in relapsed/refractory multiple myeloma

Elranatamab is a bispecific antibody approved for relapsed/refractory multiple myeloma, demonstrating a favorable safety profile and robust efficacy.

MHRA Reviews Safety of Five Plasma-Derived Products for vCJD Risk

The MHRA has completed a review of five plasma-derived medicinal products regarding their safety related to vCJD risk.

MHRA Approves UK Plasma Donations for Key Medicinal Products

The MHRA has approved the use of UK-donor plasma for five high-priority plasma-derived medicinal products.

Study Comparing Single-Dose vs Divided-Dose G-CSF for Stem Cell Mobilization

A clinical trial is underway to compare the efficacy of single-dose versus divided-dose G-CSF in healthy stem cell donors.

NCI Study to Collect Samples for Hairy Cell Leukemia and Immunotoxin Development

The National Cancer Institute is collecting samples from leukemia patients and healthy volunteers to study hairy cell leukemia and develop immunotoxins.

Long-term follow-up study on hematopoietic stem cell transplantation and therapies

A long-term follow-up study is being conducted to assess the effects of hematopoietic stem cell transplantation, cellular therapy, and gene therapy on patients and donors.

FDA Approval Status for Tranexamic Acid by Micro Labs

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Tranexamic Acid submitted by Micro Labs.

Risk of Severe Harm from Incorrect Blood Transfusion Administration Sets

Using an IV infusion giving set instead of a blood transfusion giving set poses a risk of serious harm to patients.

AstraZeneca Investigates Safety of Ondexxya IV Injection in Real-World Use

AstraZeneca is conducting a survey to assess the safety and effectiveness of Ondexxya IV Injection 200 mg in real-world conditions.

FDA Grants Approval for Mylan's Ferric Carboxymaltose ANDA217076

The FDA has granted approval for Mylan's Abbreviated New Drug Application (ANDA) for Ferric Carboxymaltose.

Study to Enhance Hydroxyurea Adoption for Sickle Cell Disease in Nigeria

A study aims to improve hydroxyurea adoption for sickle cell disease in Nigeria, addressing significant provider-level barriers.

Phase Ib/II Trial of Sonrotoclax and BCMA Bispecific Antibody in Systemic AL Amyloidosis

A phase Ib/II trial is evaluating sonrotoclax plus dexamethasone in newly diagnosed systemic AL amyloidosis patients based on t(11;14) genetic stratification.

Teclistamab Combination Study in Multiple Myeloma Initiated by Janssen

A new clinical trial is underway to evaluate the safety and tolerability of teclistamab in combination with other anticancer therapies for multiple myeloma.

FDA Grants Approval for Biocon's Eltrombopag Olamine under ANDA220660

The FDA has granted approval for Biocon Pharma's ANDA220660 for Eltrombopag Olamine.

Eugia Pharma's Tranexamic Acid Supplement Application Receives AP Status from FDA

The FDA has granted an Abbreviated New Drug Application (ANDA) AP status for Eugia Pharma's Tranexamic Acid.

Telerehabilitation vs Face-to-Face Care in Hemophilia Patients: A Comparative Study

A randomized controlled trial is assessing the effectiveness of telerehabilitation compared to face-to-face care for adults with hemophilia and chronic pain.

Pacritinib trial for Myelodysplastic Syndromes in adults and children initiated by NCI

A clinical trial is underway to evaluate pacritinib in patients aged 12 and older with Myelodysplastic Syndromes (MDS) and MDS/MPN.

FDA Acceptance of Supplemental NDA for REVLIMID by Bristol Myers Squibb

The FDA has accepted a supplemental NDA for REVLIMID (lenalidomide) submitted by Bristol Myers Squibb.

Gerofit Exercise Intervention Study for Sickle Cell Disease Shows Promise

The SICKLE-FIT study aims to evaluate a personalized exercise program for older adults with sickle cell disease.

Lisaftoclax Evaluated for Preventing Differentiation Syndrome in APL Patients

A clinical trial is underway to evaluate the efficacy and safety of Lisaftoclax in preventing differentiation syndrome in patients with acute promyelocytic leukemia receiving ATRA/ATO treatment.

AstraZeneca initiates Phase I/II trial of AZD9829 for CD123+ hematological malignancies

AstraZeneca is conducting Phase I/II trial to evaluate AZD9829 in patients with CD123+ hematological malignancies.

Phase 2 Study of Ruxolitinib in Chronic Myelomonocytic Leukemia Shows Potential for Improved Outcomes

A Phase 2 expansion study is underway to evaluate the efficacy of ruxolitinib in patients with CMML.

Regeneron initiates trial for pozelimab + cemdisiran in PNH patients unresponsive to C5 inhibitors

Regeneron is conducting a study to evaluate the efficacy of pozelimab and cemdisiran in PNH patients inadequately controlled by existing therapies.

Eli Lilly initiates Phase 1 trial of oral IDH inhibitor LY3410738 in hematologic malignancies

Eli Lilly is conducting Phase 1 trial of LY3410738, targeting patients with IDH1 or IDH2 mutations in advanced hematologic malignancies.

Phase II/III Trial Evaluates Azacitidine with Lenalidomide or Vorinostat in Myelodysplastic Syndromes

A randomized phase II/III trial is investigating the efficacy of azacitidine combined with lenalidomide or vorinostat in patients with higher-risk myelodysplastic syndromes or chronic myelomonocytic leukemia.

FDA Accepts Supplement Application for RYTELLO (Imetelstat Sodium)

The FDA has accepted the supplemental application for RYTELLO, an imetelstat sodium product.

Phase I Trial of Pacritinib with Venetoclax and Azacitidine for Myeloproliferative Neoplasms

A Phase I trial is investigating the combination of pacritinib, venetoclax, and azacitidine for treating accelerated and blast phase myeloproliferative neoplasms.

GSK's Belantamab Mafodotin Study Targets Multiple Myeloma with Renal Impairment

A study is underway to evaluate the safety and pharmacokinetics of belantamab mafodotin in multiple myeloma patients with varying degrees of renal impairment.

FDA Approves Casgevy for Young Children with Sickle Cell Disease

The FDA has granted supplemental approval for Casgevy for young children with sickle cell disease and transfusion-dependent β thalassemia.

Novartis initiates pediatric study for asciminib in Chronic Myeloid Leukemia

Novartis is conducting a study to evaluate the dose and safety of asciminib in pediatric patients with Chronic Myeloid Leukemia.

FDA Accepts Supplement Application for BESREMI (Ropeginterferon Alfa-2b-NJFT)

The FDA has accepted the supplemental application for BESREMI, a treatment involving Ropeginterferon Alfa-2b-NJFT.

FDA Approves Ferric Carboxymaltose ANDA212572 by Mylan Labs

The FDA has approved the Abbreviated New Drug Application (ANDA) for Ferric Carboxymaltose submitted by Mylan Labs.

FDA Approves ANDA217769 for Ferric Carboxymaltose by Mylan

The FDA has granted approval for the Abbreviated New Drug Application ANDA217769 for Ferric Carboxymaltose submitted by Mylan.

FDA Approves Allogeneic T Cell Immunotherapy for Hematologic Malignancies

The FDA has approved a new allogeneic regulatory T cell-based immunotherapy for use in matched donor hematopoietic stem cell transplantation.

FDA Approves TREGZI for Chronic GVHD in Blood Cancer Patients

The FDA has approved TREGZI, the first Treg cell-based immunotherapy for chronic GVHD-free survival in blood cancer patients.

FDA Drug Trials Snapshot: YARTEMLEA Approved for TA-TMA

YARTEMLEA has been approved for treating TA-TMA in patients aged 2 and older.

Trial Evaluating Levofloxacin for Infection Prophylaxis in MDS and AML Patients

A randomized controlled trial is assessing the safety and effectiveness of levofloxacin in reducing infection risk in MDS and AML patients undergoing outpatient chemotherapy.

Phase II Trial of MRD-Guided Zanubrutinib and Sonrotoclax in High-Risk CLL/SLL Patients

A phase II clinical trial is underway to evaluate the efficacy and safety of zanubrutinib combined with sonrotoclax in treatment-naïve high-risk CLL/SLL patients.

Lilly's Jaypirca recommended for EU approval in CLL across all therapy lines

The CHMP has issued a positive opinion for Lilly's Jaypirca (pirtobrutinib) for adults with CLL.

Study on Gynecological Complications Post Stem Cell Transplantation

A study is investigating the prevalence of gynecological complications in women after allogeneic hematopoietic stem cell transplantation.

Study on Factors Regulating Mast Cell Proliferation in Mastocytosis

A study is being conducted to examine growth factors affecting mast cell proliferation in patients with mastocytosis.

JNJ-68284528 (cilta-cel) vs Standard Therapy in Multiple Myeloma Study Initiated

A study is underway comparing the efficacy of JNJ-68284528 (cilta-cel) against standard therapies in multiple myeloma.

IRON-DEP Study Evaluates IV vs Oral Iron for Postpartum Depression in Anemia

The IRON-DEP Study aims to compare the efficacy of intravenous and oral iron treatments on postpartum depression prevalence in women with moderate iron deficiency anemia post-caesarean.

Novartis conducts safety study of Iptacopan in PNH patients using registry data

Novartis is conducting a post-authorization safety study of Iptacopan in adult PNH patients using data from the IPIG PNH registry.

Phase I Trial of Lentiviral Gene Therapy for Hemophilia A Initiated

A Phase I trial is underway to evaluate the safety and efficacy of lentiviral gene therapy for hemophilia A.

Agios Pharmaceuticals' Mitapivat Shows Promise in Non-Transfusion-Dependent Thalassemia Study

A study is evaluating the efficacy and safety of mitapivat in patients with non-transfusion-dependent thalassemia.

Study on APL-like Acute Myeloid Leukemia and Vascular Complications Initiated

A multicenter observational study is investigating the APL-like subset of acute myeloid leukemia as a predictor of coagulopathy and early vascular events.

FDA Grants Approval for Eltrombopag Olamine ANDA208815

The FDA has granted approval for ANDA208815, a generic version of Eltrombopag Olamine by Actavis Labs.

FDA Grants Approval for Fostamatinib Disodium ANDA217329

The FDA has granted approval for ANDA217329, a generic application for Fostamatinib Disodium submitted by Annora Pharma.

FDA Grants Priority Review for Pfizer's Marstacimab (BLA761369)

The FDA has granted priority review status for Pfizer's BLA761369, containing the active ingredient Marstacimab.

Phase I/II Trial of 211At-BC8-B10 in High-Risk Acute Leukemia and Myelodysplastic Syndrome

A phase I/II trial is evaluating the safety and dosing of 211At-BC8-B10 followed by donor stem cell transplant in patients with relapsed or refractory high-risk acute leukemia or myelodysplastic syndrome.

Development of Pediatric cGVHD Symptom Scale to Enhance Patient Reporting

A new questionnaire for assessing symptoms of chronic graft-versus-host disease in children/adolescents is being developed.

FDA Grants Priority Review for Pfizer's Marstacimab (HYMPAVZI) Supplement

The FDA has granted priority review status for the supplemental application of Marstacimab (HYMPAVZI) by Pfizer.

Venetoclax-Dexamethasone Trial for t(11;14) Relapsed/Refractory Amyloidosis Initiated

A clinical trial is underway to evaluate the safety and efficacy of venetoclax combined with dexamethasone for relapsed or refractory t(11;14) light chain amyloidosis.

Study on Hemato-immunological Parameters in Immune Thrombocytopenic Purpura

A study is underway to identify hemato-immunological parameters that predict the chronicity of Immune Thrombocytopenic Purpura (ITP) and differences between pediatric and adult populations.

Lilly to present positive Phase 3 results for pirtobrutinib in CLL at EHA 2026

Apotex Inc. Submits ANDA for Ruxolitinib

Apotex Inc. has submitted an Abbreviated New Drug Application (ANDA) for Ruxolitinib, indicating a move to enter the market.

Nemtabrutinib Study vs Ibrutinib/Acalabrutinib in 1L CLL/SLL Initiated

A study is underway to evaluate nemtabrutinib against ibrutinib or acalabrutinib in treatment-naive CLL/SLL patients.

European Commission Approves Pfizer’s HYMPAVZI for Hemophilia A and B Treatment

The European Commission has approved HYMPAVZI for treating hemophilia A or B in patients 12 years and older with inhibitors, based on Phase 3 data showing significant bleed reduction.

Roche and Nurix Collaborate on BTK Degrader Bexobrutideg for B-cell Malignancies

Roche has entered a collaboration with Nurix Therapeutics to co-develop bexobrutideg, a novel BTK degrader targeting B-cell malignancies, immunology, and neurology.

Lilly's Jaypirca shows 45% reduction in disease progression risk in CLL/SLL

Jaypirca (pirtobrutinib) significantly reduced the risk of disease progression or death by 45% when added to a venetoclax regimen in previously treated CLL/SLL patients.

Lilly presents promising Phase 1 data for first-in-class type II JAK2 inhibitor in myelofibrosis

Lilly's AJ1-11095, a type II JAK2 inhibitor, shows an encouraging safety profile and promising clinical activity in myelofibrosis patients.

FDA Approves Pfizer’s HYMPAVZI for Expanded Hemophilia A and B Indications

The FDA has approved an expanded indication for Pfizer’s HYMPAVZI to treat hemophilia A or B in patients aged 6 and older, including those with inhibitors.