December 20, 2024
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
FDA Reaffirms End of Tirzepatide Shortage, Impacting Compounders
FDA, tirzepatide, GLP-1, drug shortage, compounders, Eli Lilly, Mounjaro, Zepbound
GSK’s Zejula-Jemperli Combination Achieves Primary Endpoint in Ovarian Cancer Trial, Falls Short on Overall Survival
GSK, Zejula, Jemperli, ovarian cancer, FIRST trial, progression-free survival, overall survival
CagriSema Achieves 22.7% Weight Loss in Phase 3 REDEFINE 1 Trial, Falling Short of 25% Target
CagriSema, Weight Loss, Phase 3 REDEFINE 1 Trial, Obesity Treatment, Novo Nordisk, Semaglutide, Cagrilintide
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 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
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
Idorsia’s Restructuring Efforts Continue: Layoffs On Track Despite Delayed Sale of Hypertension Drug Tryvio
Idorsia, Restructuring, Layoffs, Tryvio, Hypertension drug, Aprocitentan, Cost-saving measures, Financial sustainability
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
Congress Passes Slimmed-Down Continuing Resolution, Extends Telehealth Flexibilities and Includes PBM Reform
Continuing Resolution, Telehealth Flexibilities, PBM Reform, Healthcare Package, Medicare, Medicaid