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.
FDAFDA 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.
FDAEMA 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.
EMAFDA 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.
FDAFDA 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.
FDAEMA, 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.
EMAANVISA 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.
ANVISAFDA Issues Draft Guidance to Accelerate Cell and Gene Therapies for Patients
FDA draft guidance proposes leveraging existing platform knowledge to streamline development of cell and gene therapies for rare and life-threatening diseases.
FDAETF Recommends Updating COVID-19 Vaccines to Target XFG Variant
EMA's Emergency Task Force recommends updating COVID-19 vaccines to target the XFG variant for the 2026/2027 vaccination campaign.
EMA