ProvayBlue Now Available in New Single-Dose Vials for Methemoglobinemia
The new ProvayBlue presentation is supplied in a box of five 10mL single-dose vials; each vial contains 50mg of methylene blue.
Miscellaneous Hematological Agents
New Dosing Regimen Approved for Gazyva in Follicular Lymphoma
For patients with follicular lymphoma who do not experience a grade 3 or higher IRR during Cycle 1, Gazyva may now be administered as a 90-minute infusion.
Red Cross Says Blood Shortage Is Worst in a Decade
Organization has had to limit blood product distributions to hospitals
Zydelig US Indications Withdrawn for Follicular Lymphoma, Small Lymphocytic Leukemia
Continued approval required further verification and description of clinical benefit in confirmatory trials.
FDA Extends Review Period for Gene Therapies for Beta-Thalassemia, Cerebral Adrenoleukodystrophy
The FDA extended the target dates for beti-cel and eli-cel to allow time to review additional clinical information for both applications.
Red Cross Says US Blood Supply at Dangerously Low Level
People who have received COVID-19 vaccines can donate blood and platelets as long as they are symptom-free
Novel NMDA Receptor Blocker Designated Orphan Drug for Subarachnoid Hemorrhage
NP10679 is an investigational subunit-specific NMDA receptor inhibitor.
Daratumumab/Hyaluronidase-fihj With Carfilzomib, Dexamethasone Approved for Multiple Myeloma
Results showed an overall response rate of 84.8%.
Lack of Confirmatory Trials Leads to Withdrawal of Multiple Myeloma Treatment
Continued approval required further verification and description of clinical benefit in confirmatory trials.
One-Time Gene Therapy Gets Priority Review for Beta-Thalassemia
Betibeglogene autotemcel (beti-cel) is a one-time gene therapy that works by adding functional copies of a modified form of the β-globin gene into a patient’s own hematopoietic stem cells.
