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 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 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FDA Issues Draft Guidance to Accelerate Cell and Gene Therapies for Patients
FDA draft guidance proposes leveraging existing platform knowledge to streamline development of cell and gene therapies for rare and life-threatening diseases.
FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs
FDA draft guidance aims to reduce unnecessary animal testing in nonclinical safety assessments for certain cancer drugs, potentially accelerating timelines for human trials.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 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.
FDA Advances Drug Repurposing to Address Unmet Medical Needs
FDA is soliciting public input on drug repurposing to accelerate treatments for chronic and rare diseases.
FDA Intensifies Efforts to Import Lower-Cost Drugs
FDA Intensifies Efforts with States to Import Lower-Cost Canadian Drugs.
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