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.
FDAFDA 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.
FDAFDA 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.
FDAEMA Fast Tracks Review of Daraxonrasib for Metastatic Pancreatic Cancer
EMA's CHMP starts phased review of daraxonrasib, a medicine for metastatic pancreatic cancer, to accelerate assessment for patients with limited treatment options.
EMAMarketing Authorisation for Tavneos (Avacopan) Recommended for Revocation
CHMP recommends revoking Tavneos' EU marketing authorisation after finding that the pivotal Advocate study data are incorrect and misleading due to GCP breaches.
EMAFDA 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.
FDAFDA 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.
FDAFDA 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.
FDAFDA 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.
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