BioSpace looks at the 10 biggest drug approvals of 2021, headlined by Biogen’s Aduhelm (aducanumab) for Alzheimer’s disease and Pfizer and BioNTech’s COVID-19 vaccine Comirnaty.
After the historic approval of the company’s first-ever drug in January 2021, Aurinia Pharmaceuticals announced the acquisition of two pipeline assets that align with the Canadian biotech’s focus on autoimmune and kidney-related disease.
The U.S. Food and Drug Administration approved Aurinia Pharmaceuticals Inc.’s Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis.
FDA Action Alert: Merck, Aurinia and AmgenAmgen, Business, Calcineurin Inhibitors (CNI), Chronic Heart Failure, Clinical Trials, Collaborations, Deals, FDA, FDA, Hematopoietic Syndrome of Acute Radiation Syndrome (H-ARS), Lupus nephritis, Merck, Myelosuppression, New Drug Application (NDA), PDUFA, Priority Review, R&D, Systemic Lupus Erythematosus (SLE)
After a start-of-the-year lull, activities at the U.S. Food and Drug Administration are starting to pick up, according to BioSpace.
The U.S. Food and Drug Administration approved GlaxoSmithKline plc’s Benlysta (belimumab) for the treatment of adult patients with active lupus nephritis who are receiving standard therapy.
Novartis won the go-ahead from the U.S. Food and Drug Administration to conduct a randomized trial of the malaria drug hydroxychloroquine against COVID-19 disease to see if the medicine helps patients.
Roche won the U.S. Food and Drug Administration’s breakthrough therapy tag for Gazyva in lupus nephritis, boosting the Swiss drugmaker’s efforts to recycle the 2013-approved lymphoma medicine for new indications.
Yale Researchers Discover Immune System Protein That Can Help Suppress HIVApobec3A (A3A) protein, Cells, FDA, Gene Expression, HIV, Immune System, Lupus nephritis, Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), R&D, T-Cells, U.S. Centers for Disease Control and Prevention, Viral Genes, Viruses
A new report released by researchers at Yale University could change the way some HIV patients are treated.