Hematology
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This agent has already received indications in Japan for relapsed or refractory DLBCL and other large B-cell lymphomas.
Amneal has received FDA Approval for lenalidomide capsules in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg strength.
The oral agent is currently under evaluation in a first-in-human phase I trial for use in relapsed or refractory disease.
Patients with follow-up of one month or longer saw hemolysis marker improvement and reported no vaso-occlusive crises.
Approval issued for adults ineligible for CAR T-cell therapy or autologous transplant after two or more systemic therapies.
The phase III MIRACLE trial is evaluating annamycin combined with cytarabine for relapsed or refractory AML.
In a phase III trial 90% of evaluable patients were free of severe vaso-occlusive crisis for at least 12 consecutive months.
A prospective study involved ultrasound imaging of patients' carotid arteries to evaluate for structural changes.
Further study is needed to determine if a particular eGFR biomarker best predicts cardiovascular risks.
Reni-cel led to hemoglobin normalization and increased fetal hemoglobin in patients with sickle cell disease.
In the phase II TRANSCEND FL trial the CAR T-cell therapy has shown good efficacy and manageable safety in MZL and FL.
The menin inhibitor oral agent achieved the KOMET-001 trial's primary endpoints and had a favorable benefit-risk profile.
An expert panel's review finds SCT has often been misattributed as the direct cause of mortality in patients who have SCT.
A study cohort with severe disease over a median follow-up of 14 months had an annualized bleeding rate of zero.
Use is also being explored for T-cell acute lymphoblastic leukemia, chronic lymphocytic leukemia, and mantle cell lymphoma.
Clinicians can use this test to help distinguish more than 60 disease subtypes from patients' normal immune response.
The new agent is on the 505(b)(2) regulatory pathway and was compared with tablet-form apixaban in 60 healthy volunteers.
Organization-level changes at hospitals and medical groups are needed to meaningfully address this longstanding issue.
The new indication is for use of the alkylating agent with fludarabine in a preparatory combination for allogeneic HSCT.
Dapsone demonstrates efficacy and acceptable safety with low costs as treatment for pediatric ITP.
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