United States Food and Drug Administration
FDA Issues Boxed Warning for Anaphylaxis Risk with Multiple Sclerosis Drugs Copaxone and Glatopa
FDA, boxed warning, anaphylaxis, multiple sclerosis, Copaxone, Glatopa, glatiramer acetate, Teva, Sandoz
FDA Adds Boxed Warning to Teva’s Copaxone and Generic Glatopa Due to Anaphylaxis Risk
FDA Boxed Warning, Anaphylaxis Risk, Copaxone, Glatopa, Glatiramer Acetate, Multiple Sclerosis (MS) Treatment, Allergic Reaction
FDA Places Clinical Hold on Atara Biotherapeutics’ EBVALLO and ATA3219 Due to Manufacturing Compliance Issues
Atara Biotherapeutics, FDA clinical hold, EBVALLO, ATA3219, allogeneic T-cell therapies, manufacturing compliance issues, GMP compliance, Epstein-Barr virus, post-transplant lymphoproliferative disease, non-Hodgkin’s lymphoma, systemic lupus erythematosus.
Trump’s Second Term: Mifepristone Battle Looms as Early Test of Abortion Stance
Mifepristone, abortion, Trump, second term, reproductive rights, FDA, Supreme Court
Sanofi Assures No Supply Disruptions Following FDA Warning Letter for US Manufacturing Site
Sanofi, FDA warning letter, US manufacturing site, supply interruptions, CGMP deviations
Atara Biotherapeutics Faces Clinical Hold on EBVALLO and Pipeline Candidate Due to Manufacturing Site Inspection Issues
Atara Biotherapeutics, EBVALLO, Clinical Hold, FDA, Manufacturing Site Inspection, Cell Therapy, T-Cell Immunotherapy
FDA Urges Enhanced Authority to Combat Pediatric and Neonatal Medical Device Shortages
FDA, Medical Device Shortages, Pediatric Patients, Neonatal Patients, Supply Chain Vulnerabilities, Regulatory Authority
AstraZeneca Secures Full FDA Approval for Lymphoma Treatment Selected by CMS
AstraZeneca, FDA Approval, Lymphoma Treatment, CMS-Selected
AstraZeneca’s Calquence Gains FDA Approval as First-Line Treatment for Mantle Cell Lymphoma
AstraZeneca, Calquence, acalabrutinib, BTK inhibitor, mantle cell lymphoma, first-line treatment, FDA approval
Appeals Court Upholds FDA’s Denial of Fast Track Designation for Vanda’s Gastroparesis Drug
FDA, Vanda Pharmaceuticals, Fast Track Designation, Gastroparesis, Drug Approval Process