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 EMA 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.
EMA 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 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 EMA, 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.
EMA FDA Issues Draft Guidance to Accelerate Cell and Gene Therapies for Patients
FDA draft guidance proposes leveraging existing platform knowledge to streamline development of cell and gene therapies for rare and life-threatening diseases.
FDA ETF 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EMA FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs
FDA draft guidance aims to reduce unnecessary animal testing in nonclinical safety assessments for certain cancer drugs, potentially accelerating timelines for human trials.
FDA EU recommendations for 2026/2027 seasonal flu vaccine composition
Annual updates to virus strains ensure vaccines stay effective
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