Marketing 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.
InstitutionsFDA 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.
InstitutionsFDA 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.
InstitutionsFDA 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.
InstitutionsFDA 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.
InstitutionsFDA 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.
InstitutionsFDA 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.
InstitutionsEMA 2025 Annual Report: Strong Approvals for Human and Veterinary Medicines
EMA's 2025 annual report shows 104 human and 30 veterinary medicines recommended, marking the agency's 30th anniversary.
InstitutionsFDA 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.
InstitutionsFDA 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.
InstitutionsEMA, AMA and African Regulators Join Forces on Ebola Outbreak Response
EMA's Emergency Task Force collaborates with AMA and African regulators to advance clinical trials and medical countermeasures for the Bundibugyo Ebola outbreak in the DRC and Uganda.
InstitutionsANVISA Updates Health Measures for Ports and Airports Amid Ebola Outbreak
Brazilian Health Regulatory Agency updates port and airport health protocols after WHO declares Ebola outbreak in Congo a Public Health Emergency of International Concern.
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