Pegcetacoplan Approved for Paroxysmal Nocturnal Hemoglobinuria
The U.S. Food and Drug Administration (FDA) has approved the targeted C3 inhibitor pegcetacoplan for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria...
Orelabrutinib Receives Breakthrough Therapy Designation for Mantle Cell Lymphoma
The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to the selective Bruton tyrosine kinase (BTK) inhibitor orelabrutinib for the treatment...
Biden Selects Danielle Carnival to Help Lead Cancer Moonshot
President Joe Biden has selected Danielle Carnival, PhD, to work “on patient engagement and outreach,” for the administration’s Cancer Moonshot, according to a White...
Cancer Treatment Costs in the U.S. Rose Faster Than European Countries
A new study published in JAMA Oncology found that prices for dozens of cancer treatments were significantly higher when introduced into the U.S. market,...
FDA Recommends Expanding Clinical Trial Eligibility for Patients with Incurable Cancers
The U.S. Food and Drug Administration (FDA) has issued draft guidance for expanding investigational clinical trial options for patients with incurable cancers, encouraging sponsors...
Dabigatran Etexilate Approved for Children with VTE
The U.S. Food and Drug Administration (FDA) has approved dabigatran etexilate oral pellets for the treatment of children ages three months to 12 years...
One-Quarter of Americans Covered Under Medicaid During the Pandemic
A recent government report revealed that nearly 10 million Americans enrolled in Medicaid during the COVID-19 pandemic, with a record 80 million people –...
FDA Clears IND Application for Gamma Delta T-Cell Therapy
The FDA has cleared an investigational new drug (IND) application for GDX012 to be examined as a therapy for patients with hematologic malignancies. GDX012...
FDA Revives Unapproved Drugs Initiative
The FDA is reversing the Trump administration’s decision to end the Unapproved Drugs Initiative.
This program, which launched in 2006, requires pharmaceutical manufacturers to seek...
Sickle Cell Trait Cited in Police Custody Deaths
In a review of data on suspicious deaths from more than 30 of the largest U.S. counties, The New York Times found that sickle...
Current Issue
July 2021 Bonus Mid-Year Edition, Volume 7 Issue 9
This issue features conversations with ASH Clinical Research Training Institute graduates, highlights from the virtual ASCO and EHA annual meetings, and more.