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BioWorld - Wednesday, March 18, 2026

FDA

Home » Topics » Regulatory » FDA
  • Ocular eye analysis
    March 17, 2026

    Aldeyra collects third CRL for reproxalap in dry eye disease

    It’s déjà vu all over again for Aldeyra Therapeutics Inc., which disclosed its third complete response letter (CRL) for dry eye disease candidate reproxalap, with the U.S. FDA citing a lack of substantial and consistent evidence of efficacy.
  • Glp 1 capsule
    March 17, 2026
    By Marian (YoonJee) Chu

    Structure’s oral GLP-1 data mark bullish year for obesity pills

    The GLP-1 fight has moved from injectables to pills, and Structure Therapeutics Inc. is in the ring with phase III-ready aleniglipron. According to the Bay Area biotech, its oral once-daily glucagon-like peptide-1 (GLP-1) drug candidate, aleniglipron, demonstrated an absolute weight loss of “up to 39 pounds” in the 44-week Access II trial.
  • Epilepsy illustration
    March 16, 2026

    Unixell Biotech’s UX-GIP001 gains IND clearance for epilepsy

    Shanghai Unixell Biotechnology Co. Ltd. has obtained IND clearance from the FDA for UX-GIP001, its iPSC-derived allogeneic cell therapy for focal epilepsy. A phase I study will evaluate UX-GIP001 in patients with drug-resistant epilepsy.
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Blog Posts

  • International standards iso
    Feb. 3, 2022
    By Mark McCarty

    Goldilocks or bust: The FDA’s regulatory harmonization dilemma

  • 08 13 blog fda
    Aug. 13, 2021
    By Mark McCarty

    Forward to the past: The FDA commissioner dilemma

  • Health care politics illustration
    Aug. 26, 2020
    By Mari Serebrov

    U.S. politicking threatens public trust in the FDA and CDC

  • Dec. 5, 2013
    By Mark McCarty

    Trust in government: 23 more reasons for suspicions

  • May 29, 2013
    By Jim Stommen

    Med-tech community wary, but at the same time optimistic about the future of the sector

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