United States Food and Drug Administration
Takeda to Discontinue Uloric: A Gradual Decline of the Gout Medication
Takeda, Uloric, gout medication, discontinuation, cardiovascular risks, FDA scrutiny
FDA Delays Decision on Stealth BioTherapeutics’ Elamipretide for Barth Syndrome Until April 2025
Barth Syndrome, Elamipretide, FDA Decision, Stealth BioTherapeutics, Drug Approval Delay
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