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BioWorld - Tuesday, July 21, 2026

FDA

Home » Topics » Regulatory » FDA
  • Red car t cell on blue blackground
    July 20, 2026
    By Marian (YoonJee) Chu

    To viral or not to viral: In vivo CAR T debates delivery tech

    The field of cell and gene therapy is moving toward a new phase of scalability and clinical durability, with in vivo chimeric antigen receptor (CAR) T-cell therapeutics emerging as the dark horse in what speakers at BIO Asia-Taiwan 2026 described as CAR T’s second revolution.
  • Financings international foreign currency
    July 16, 2026
    By Marian (YoonJee) Chu

    Capital remains selective in ‘barbell’ biotech market

    Signs of recovery are emerging in the biotechnology investment sector, although investors across Asia say that capital is flowing selectively to companies that can demonstrate clinical differentiation, strong management teams and a clear path to commercialization.
  • Lipfendra
    July 16, 2026
    By Karen Carey

    US FDA approves Merck's Lipfendra, first oral PCSK9 for LDL-C

    Branded Lipfendra, Merck & Co. Inc.’s oral PCSK9 inhibitor enlicitide, part of the FDA Commissioner’s National Priority Voucher pilot program, won U.S. approval to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia.
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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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  • Randy Osborne
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