United States Food and Drug Administration
Applied Therapeutics Undergoes Leadership Changes Amid FDA Rejection and Regulatory Challenges
Applied Therapeutics, leadership changes, FDA rejection, rare disease drug, govorestat, regulatory challenges
Breakthrough in Familial Chylomicronemia Syndrome: FDA Approves Ionis’ Tryngolza as First Treatment
Familial Chylomicronemia Syndrome (FCS), Ionis Tryngolza, FDA Approval, Rare Genetic Hyperlipidemia, Acute Pancreatitis, Lipid-Lowering Therapy
FDA Approves Humacyte’s Symvess ATEV: A Breakthrough in Regenerative Medicine for Vascular Trauma Treatment
Humacyte, FDA approval, Symvess ATEV, regenerative medicine, vascular trauma, lab-grown blood vessels
FDA Approves Ionis’s TRYNGOLZA for Familial Chylomicronemia Syndrome, a Rare Metabolic Disorder
FDA approval, Ionis Pharmaceuticals, TRYNGOLZA, olezarsen, familial chylomicronemia syndrome (FCS), rare metabolic disorder
FDA Reaffirms End of Tirzepatide Shortage, Impacting Compounders
FDA, tirzepatide, GLP-1, drug shortage, compounders, Eli Lilly, Mounjaro, Zepbound
Rhythm Pharmaceuticals Secures Expanded FDA Approval for IMCIVREE to Treat Genetic Obesity in Children as Young as 2 Years Old
Rhythm Pharmaceuticals, IMCIVREE, setmelanotide, FDA approval, genetic obesity, Bardet-Biedl syndrome, POMC, PCSK1, LEPR deficiency, pediatric obesity treatment
Applied Therapeutics Undergoes Leadership Change Amid FDA Rejection and Investor Lawsuit
Applied Therapeutics, FDA rejection, investor lawsuit, leadership change, John H. Johnson, Les Funtleyder, Shoshana Shendelman
FDA Issues Complete Response Letter for Zealand Pharma’s Glepaglutide in Short Bowel Syndrome Treatment
Zealand Pharma, Glepaglutide, GLP-2 analog, Short Bowel Syndrome (SBS), FDA rejection, Complete Response Letter
FDA Confirms Tirzepatide Availability, Compounders Express Concerns, While Semaglutide Shortage Persists
FDA, tirzepatide, semaglutide, GLP-1 drug shortage, compounders, pharmaceutical availability
Mesoblast Secures FDA Approval for Ryoncil, First Mesenchymal Stromal Cell Therapy for Pediatric Steroid-Refractory Acute Graft-Versus-Host Disease
Mesoblast, Ryoncil, FDA Approval, Mesenchymal Stromal Cell Therapy, Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD), Pediatric Patients, Cell Therapy