FDA Opens Communication Lines Between Drug Makers and Insurers
The U.S. Food and Drug Administration (FDA) has issued final guidance documents outlining the types of information that drug companies may share with insurers,...
First Pegfilgrastim Biosimilar Receives Approval
The U.S. Food and Drug Administration (FDA) has approved pegfilgrastim-jmdb, a biosimilar version of pegfilgrastim, which is indicated to decrease the duration of neutropenia...
Scientists Engineer Artificial Bone Tissue
Researchers have developed an artificial bone marrow niche, in which hematopoietic and progenitor cells are able to multiply and remain functional for several days,...
FDA Approves Avatrombopag for Thrombocytopenia
The U.S. Food and Drug Administration (FDA) has approved avatrombopag for the treatment of thrombocytopenia in adults with chronic liver disease who are scheduled...
WHO Identifies “Essential” Lab Tests
The World Health Organization (WHO) published a new list of 113 diagnostic tests that it considers “essential” to every health-care system. Called the Essential...
FDA Expands Daratumumab’s Indication to Frontline Myeloma Treatment
The U.S. Food and Drug Administration (FDA) approved a new indication for the anti-CD38 monoclonal antibody daratumumab, to include the treatment of patients who...
First Biosimilar for Anemia Treatment Approved by FDA
Epoetin alfa-epbx, a biosimilar to epoetin alfa, was approved for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine...
Trump Administration Reveals Plans to Lower Drug Prices
In May, President Donald Trump and members of his administration outlined plans to lower prescription drug prices: First, the president unveiled initiatives to remove...
FDA Cracks Down on Unapproved Stem-Cell Clinics
The U.S. Food and Drug Administration (FDA) filed complaints in May seeking permanent injunctions against two stem cell clinics, U.S. Stem Cell Clinic of...
Andexanet Becomes First FDA-Approved Antidote for Factor Xa Inhibitors
The U.S. Food and Drug Administration (FDA) granted approval to andexanet alfa, also known as coagulation factor Xa (recombinant), inactivated-zhzo, for the reversal of...
Current Issue
July 2018 Bonus Mid-Year Edition
This bonus issue features a look at the most recent changes to Maintenance of Certification programs, highlights from recent hematology/oncology meetings, and more.
