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BioWorld - Tuesday, June 2, 2026

BLA

Home » Topics » Regulatory » BLA
  • Skin exam2
    May 29, 2026
    By Jennifer Boggs

    Replimune tries again with melanoma drug post FDA shakeup

    Industry watchers will be tracking closely Replimune Group Inc.’s latest attempt to secure U.S. FDA approval of its advanced melanoma candidate, RP-1 (vusolimogene oderparepvec). The company announced Friday it had reached alignment for resubmitting the twice-rejected BLA with the agency, which it said has pledged to prioritize the review.
  • Researcher antisense oligonucleotides
    May 5, 2026
    By Marian (YoonJee) Chu

    Bio Korea 2026 kicks off with spotlight on oligonucleotides

    Three decades of trial-and-error, and the resulting safety data, in the oligonucleotide-based therapeutic space have paved way for the present-day innovations and the promise of “programmable,” precision medicine for patients, speakers at Bio Korea 2026 said April 28.
  • Green approved stamp1
    May 5, 2026
    By Marian (YoonJee) Chu

    MFDS clears Curocell’s anbal-cel as first homegrown CAR T therapy

    South Korea’s Ministry of Food and Drug Safety (MFDS) approved Curocell Inc.’s Rimqarto (anbalcabtagene-autoleucel; anbal-cel) April 29 as the first homegrown CAR T-cell therapy to treat patients with advanced diffuse large B-cell lymphomas.
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