Pfizer Gains FDA Approval for Humira Biosimilar
November 18, 2019
Expected U.S. launch in 2023.
Drew Boxler
Crizanlizumab for Sickle Cell Pain Reduction Approved by FDA
November 15, 2019
First and currently only biological targeting P-selectin.
FDA Approves Zanubrutinib for Mantle Cell Lymphoma
November 15, 2019
MCL is an aggressive form of NHL
FDA Approves Luspaterecpt-aamt for Anemia
November 12, 2019
Shown to reduce regular RBC transfusions in adults with beta thalassemia.
New Filgrastim Biosimilar Approved by FDA
November 7, 2019
Fourth filgrastim biosimilar from Sandoz, expected ASAP.
FDA Warns of Biotin Interference in Lab Assays
November 6, 2019
Could lead to falsely high or low results, especially troponin assays.
Quadrivalent Flu Vaccine Approved for Elders
November 6, 2019
Approved for ages 65 and older.
FDA Approves Talicia for Helicobacter pylori Infections
November 4, 2019
First and currently only rifabutin-based H. pylori therapy approved.
New Multiple Sclerosis Treatment Approved by FDA
October 30, 2019
Delayed-release oral capsules for various forms of the disease.
Baxdela Now Approved for Bacterial Pneumonia
October 25, 2019
Commercial launch suspended due to manufacturer liquidity.
