Indication Expanded for Gemtuzumab Ozogamicin
The FDA has extended the indication of gemtuzumab ozogamicin to include pediatric patients aged 1 month or older with newly diagnosed CD33-positive acute myeloid...
Oral Selinexor Approved for Relapsed/Refractory DLBCL
The FDA has granted accelerated approval to selinexor for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL...
White House Extends Work Visa Suspensions
The White House has announced the restriction of several categories of work visas for non-American citizens, in response to high unemployment levels following the...
FDA Releases Statistical Guidance for Clinical Trials Affected by COVID-19
The FDA has released new guidance regarding statistical considerations for clinical trials affected by the COVID-19 pandemic, with the aim of maintaining integrity of...
FDA Grants Accelerated Approval to Tazemetostat for Follicular Lymphoma
Tazemetostat, an enhancer of zeste homolog 2 (EZH2) gene inhibitor, was granted accelerated approval for two indications in adults with relapsed or refractory follicular...
CMS Proposes Higher Reimbursement Rate for CAR T-Cell Therapies
The Centers for Medicare and Medicaid Services (CMS) has proposed a new system for calculating reimbursement rates for hospitals administering chimeric antigen receptor (CAR)...
PTG-300 Receives Orphan Drug Designation for Treatment of Polycythemia Vera
The FDA granted orphan drug designation to PTG-300 for the treatment of phlebotomy-requiring polycythemia vera (PV). PTG-300 is an injectable synthetic hepcidin mimetic in...
FDA Partners With NY Health Tech Firm to Collect Real-world COVID-19 Data
The FDA announced a new research project to collect real-world data from insurance companies and electronic health records on the use of diagnostic tests...
Daratumumab and Hyaluronidase-fihj Approved For Patients With Myeloma
The FDA has approved a new subcutaneous formulation of daratumumab and hyaluronidase-fihj for adult patients with newly-diagnosed or relapsed/refractory multiple myeloma (MM). Daratumumab was...
FDA Grants Orphan Drug Designation to MT-401 for AML
The FDA has granted orphan drug designation to MT-401, an allogeneic T-cell therapy for the treatment of acute myeloid leukemia (AML).
MT-401, from Marker Therapeutics,...
Current Issue
August 2020 Volume 6, Issue 10
This issue looks at the rapid expansion of telemedicine, explores access to leukemia treatment in Brazil, and more.