FDA Approves Gilteritinib for FLT3-Mutated AML
The oral FLT3/AXL inhibitor gilteritinib was approved by the FDA for the treatment of adult patients with FLT3-mutated, relapsed or refractory AML. The FDA...
First Biosimilar for Rituximab Gains Approval
The FDA approved rituximab-abbs, the first biosimilar of rituximab, for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin lymphoma (NHL). This marks the...
FDA Approves Emapalumab for Previously Treated HLH
The U.S. Food and Drug Administration (FDA) approved emapalumab, an anti-interferon gamma monoclonal antibody, for the treatment of adults and children with primary hemophagocytic...
FDA Approves Frontline Venetoclax for AML
The BCL2 inhibitor venetoclax, in combination with azacitidine or decitabine or low-dose cytarabine, was approved by the FDA for the treatment of patients with...
Glasdegib Receives Approval for Older Patients With AML
The FDA approved glasdegib, in combination with low-dose cytarabine, for patients with newly diagnosed AML who are aged 75 years or older or who...
CMS Finalizes Physician Fee Schedule for 2019
The Centers for Medicare and Medicaid Services (CMS) released its final changes to the Medicare Physician Fee Schedule and the Quality Payment Program for...
FDA Approves Elotuzumab-Based Triplet Regimen for Myeloma
The FDA approved the combination of elotuzumab plus pomalidomide and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (MM)...
FDA Issues Draft Guidance on MRD in Clinical Trials
To make drug development and evaluation more efficient, the U.S. Food and Drug Administration (FDA) issued draft guidance on the use of minimal residual...
FDA Expands Brentuximab Vedotin’s Indication
Brentuximab vedotin has been approved in combination with chemotherapy for the firstline treatment of adult patients with certain peripheral T-cell lymphomas (PTCLs).
The FDA granted...
New Bill Bans Pharmacist Gag Orders
Congress has passed two bills prohibiting “gag clauses” in contracts between pharmacies and insurance companies or pharmacy benefit managers (PBMs). The legislation – one...
Current Issue
January 2019 Annual Meeting Edition
This issue features highlights from the 2018 ASH Annual Meeting, including big data initiatives to improve prognosis in myelodysplastic syndromes, and more.
