FDA Selects Dexcom as First Participant in TEMPO Pilot
FDA named Dexcom as the first manufacturer selected for the TEMPO for Digital Health Devices Pilot, a program pairing digital health technology with the CMS ACCESS Model to improve outcomes for people with chronic diseases.
FDA Revokes Orange B, Proposes Removing Citrus Red No. 2
FDA took two actions targeting petroleum-based color additives, revoking Orange B and proposing to revoke Citrus Red No. 2, as it continues efforts to phase out artificial dyes from the U.S. food supply.
FDA Approves Lipfendra, First Oral PCSK9 Inhibitor for High Cholesterol
FDA approves Lipfendra (enlicitide), the first oral PCSK9 inhibitor, as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia including HeFH.
FDA Proposes Rule to Modernize Drug Manufacturing Registration
FDA proposes streamlined registration for distributed drug manufacturers and clarifies foreign facility requirements under the PREVENT Pandemics Act.
FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease
FDA issues supplemental approval for Casgevy, the first CRISPR/Cas9 gene therapy, for patients 2 years and older with sickle cell disease or transfusion-dependent beta thalassemia.
FDA Approves First Treg Cell Therapy to Prevent Chronic GVHD in Blood Cancer
FDA approves Tregzi, the first regulatory T cell-based immunotherapy, to improve chronic graft-versus-host disease-free survival in adults with blood cancers undergoing stem cell transplantation.
FDA Approves First Single-Dose Generic Treatment for Influenza
FDA approves first generic of Xofluza (baloxavir marboxil), the first single-dose generic treatment for acute uncomplicated influenza and prophylaxis in patients 5 years and older.
FDA Approves Tzield (teplizumab) for Pediatric Stage 3 Type 1 Diabetes
FDA grants accelerated approval to Tzield (teplizumab) to delay decline of insulin production in pediatric patients ages 8–17 with recently diagnosed Stage 3 type 1 diabetes.
FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose
FDA approves Rextovy, another over-the-counter naloxone nasal spray for emergency treatment of opioid overdose, broadening access and consumer options.
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