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386 stories matching this filter · ← front page

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  • FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients with Recently Diagnosed Stage 3 Type 1 Diabetes
    On June 12, 2026, the U.S. Food and Drug Administration granted accelerated approval to Tzield (teplizumab) for a new indication, to delay the decline of insulin production in pediatric patients ag…
    fda press · 2mo ago↗ source
  • FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children
    The U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosensor System, an in…
    fda press · 2mo ago↗ source
  • FDA Issues Emergency Use Authorization for Generic Over-the-Counter Drug to Treat New World Screwworm in Dogs and Cats
    FDA today issued an Emergency Use Authorization (EUA) for generic Nitenpyram Tablets (nitenpyram) for the treatment of New World screwworm (NWS) infestations (myiasis) in dogs, puppies, cats, and k…
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Infectious Disease357
fda press · 2mo ago↗ source
  • FDA Expands Sunscreen Options for the First Time in 20 Years
    Today, the U.S. Food and Drug Administration added bemotrizinol to the list of permitted sunscreen active ingredients, marking a significant milestone in the agency's efforts to advance sunscreen i…
    fda press · 2mo ago↗ source
  • FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients
    The U.S. Food and Drug Administration (FDA) today issued draft guidance to help developers bring promising gene therapies to patients more efficiently by making greater use of existing scientific a…
    fda press · 2mo ago↗ source
  • FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs
    The U.S. Food and Drug Administration today issued a draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for certain cancer drugs.
    fda press · 2mo ago↗ source
  • FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
    Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarr…
    fda press · 3mo ago↗ source
  • FDA Warns Retailers Selling Illegal Tobacco Products That Look Like Everyday Products
    FDA Warns Retailers Selling Illegal Tobacco Products That Look Like Everyday Products
    fda press · 3mo ago↗ source
  • FDA Finalizes Food Chemical Safety Post-Market Assessment Program, Launches Reassessment of BHT, ADA
    FDA continues to implement its bold food agenda, with two decisive actions focused on food chemical safety.
    fda press · 3mo ago↗ source
  • Fierce Biotech Layoff Tracker 2026: Kolon cuts workforce after ph. 3 fail; Sanofi sheds 229 staffers
    As always, if you know of layoffs occurring at a biotech, please reach out to the Fierce Biotech editorial team.
    Fierce Biotech · 8mo ago↗ source
  • Fierce Biotech Fundraising Tracker '26: Abcuro secures $66M; InduPro assembles $77M
    The Fierce Biotech Fundraising Tracker records venture capital rounds of $50 million or more secured by biotechs.
    Fierce Biotech · 8mo ago↗ source