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.
FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children
FDA clears Dexcom's Stelo Glucose Biosensor System as the first over-the-counter continuous glucose monitor for children ages 2 and older who do not use insulin.
FDA Authorizes Generic Nitenpyram for New World Screwworm in Dogs and Cats
FDA issues Emergency Use Authorization for generic Nitenpyram Tablets to treat New World screwworm infestations in dogs and cats weighing at least two pounds.
FDA Expands Sunscreen Options for the First Time in 20 Years
FDA adds bemotrizinol to approved sunscreen ingredients, the first new active sunscreen ingredient in 20 years, used safely in Europe for decades.
FDA Issues Draft Guidance to Accelerate Cell and Gene Therapies for Patients
FDA draft guidance proposes leveraging existing platform knowledge to streamline development of cell and gene therapies for rare and life-threatening diseases.