FDA Halts Trials of Venetoclax for Myeloma
The U.S. Food and Drug Administration (FDA) has issued a warning to health-care professionals and clinical investigators about the risks associated with the investigational...
FDA’s ODAC Rejects Selinexor for Myeloma
In an 8-to-5 vote, the U.S. Food and Drug Administration's (FDA’s) Oncologic Drug Advisory Committee (ODAC) decided against recommending accelerated approval of selinexor for...
Biomedical Research Community Concerned About Cuts in Proposed 2020 Budget
On March 11, President Donald Trump released his proposed fiscal year 2020 budget, called “A Budget for a Better America,” that includes a substantial...
FDA Alerts Patients About Blood Clot and Mortality Risk With Tofacitinib
The U.S. Food and Drug Administration (FDA) has issued a Safety Announcement for the Janus kinase (JAK) inhibitor tofacitinib after a required postmarketing trial...
Scott Gottlieb Resigns as FDA Commissioner
On March 5, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, announced his resignation, citing a desire to spend more time with...
Ibrutinib and Obinutuzumab Combo Granted Approval for CLL/SLL
The U.S. Food and Drug Administration (FDA) approved the combination of ibrutinib and obinutuzumab for the treatment of patients with treatment-naïve chronic lymphocytic leukemia/small...
FDA Approves Caplacizumab-yhdp for Acquired TTP
Caplacizumab-yhdp, a bivalent anti–von Willebrand factor nanobody, was approved for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with...
Liquid Biopsy Test Cleared for Use in CML
The U.S. Food and Drug Administration approved the QXDx AutoDG ddPCR System, a liquid biopsy test designed to precisely and reproducibly monitor molecular response...
New Treatment Approved for Hemophilia A
The U.S. Food and Drug Administration approved turoctocog alfa pegol, an extended half-life factor VIII (FVIII) molecule formerly known as N8-GP, for the treatment...
FDA Warns Consumers About “Young Blood” Plasma Infusions
Responding to the rising popularity of “anti-aging” plasma infusions from young adults, the U.S. Food and Drug Administration (FDA) has warned consumers that the...
Current Issue
May 2019, Volume 5, Issue 6
This issue features a look at home-based care for hematologic disorders, strides in pediatric leukemia in El Salvador, and more.
