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BioWorld - Saturday, May 16, 2026

FDA

Home » Topics » Regulatory » FDA
  • Abstract blue human heart with red cardio pulse line and red circle
    May 14, 2026

    KHN-921 gains IND clearance for MYBPC3-associated HCM

    Chengdu Origen Biotechnology Co. Ltd. and Vanotech Ltd. have announced IND clearance by the FDA for KHN-921 for the treatment of hypertrophic cardiomyopathy (HCM) associated with MYBPC3 mutations.
  • Mantle cell lymphoma
    May 13, 2026
    By Jennifer Boggs

    Beone’s BCL2 drug Beqalzi wins FDA nod in mantle cell lymphoma

    A few months after winning its first regulatory clearance in China, Beone Medicines Inc.’s next-generation BCL2 inhibitor, sonrotoclax, gained the U.S. FDA’s accelerated approval for use in patients with relapsed or refractory mantle cell lymphoma (MCL) following treatment with a BTK inhibitor. The therapy, branded Beqalzi, marks the first BCL2-targeting drug for MCL in the U.S., but the company has pointed to a bigger opportunity in the potential combination with blockbuster BTK drug Brukinsa (zanubrutinib).
  • China and us flags
    May 13, 2026
    By Mari Serebrov

    Life sciences ‘sweet’ opportunity in US-China talks

    Of all the issues that could be on the table at the talks between U.S. President Donald Trump and China President Xi Jinping, the life sciences sector is the “sweet spot” for collaboration between the two countries in a way that would benefit the world, Sen. Thom Tillis, R-N.C., said in a Brookings Institution webinar in advance of the two-day summit that starts May 14.
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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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