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.
Regulatory 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.
Regulatory 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.
Regulatory 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.
Regulatory 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.
Regulatory FDA Issues Draft Guidance to Accelerate Cell and Gene Therapies for Patients
FDA draft guidance proposes leveraging existing platform knowledge to streamline development of cell and gene therapies for rare and life-threatening diseases.
Regulatory 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.
Regulatory FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs
FDA draft guidance aims to reduce unnecessary animal testing in nonclinical safety assessments for certain cancer drugs, potentially accelerating timelines for human trials.
Regulatory EU recommendations for 2026/2027 seasonal flu vaccine composition
Annual updates to virus strains ensure vaccines stay effective
Regulatory EMA Recommends First Oral GLP-1 Treatment for Weight Management
EMA recommends first oral GLP-1 (semaglutide) for weight management, offering Wegovy tablets as an alternative to injections.
Regulatory Lab Lexicon Now Available in German
Lab Lexicon adds German as its seventh language, making laboratory science more accessible to German-speaking scientists worldwide.
Meta FDA Finalizes Food Chemical Safety Program, Launches Reassessment of BHT and ADA
FDA finalized its post-market assessment program for food chemicals and launched reassessments of BHT and ADA.
RegulatoryShowing 1 to 12 of 16 results