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BioWorld - Saturday, April 18, 2026

Regulatory

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Home » Topics » Regulatory
  • Erica schwartz nominee for cdc director 4 17
    April 17, 2026
    By Mari Serebrov

    New nominee may need a charm at the CDC

    As U.S. President Donald Trump’s third nominee for CDC director, Erica Schwartz will soon find out if three times really is a charm. Trump announced the nomination on social media April 16, touting Schwartz’s credentials for the job. Calling her “incredibly talented,” Trump cited her “distinguished career” as a military doctor, in the Navy and Coast Guard, and her service as deputy surgeon general during his first term in office.
  • Arrows opposite directions
    April 17, 2026
    By Marian (YoonJee) Chu

    Daiichi to divest consumer health unit to Suntory for $1.5B

    Daiichi Sankyo. Co. Ltd. will begin a phased sale of its consumer health subsidiary, Daiichi Sankyo Healthcare Co. Ltd., to Suntory Holdings Ltd., as the Tokyo-based drugmaker sharpens its focus on oncology.
  • Acute myeloid leukemia
    April 17, 2026
    By Tamra Sami

    Delta-Fly eyes NDA path despite AML phase III miss

    Delta-Fly Pharma Inc. is pressing ahead with discussions with the FDA for its lead acute myeloid leukemia (AML) candidate, radgocitabine (DFP-10917), despite a phase III miss on its primary endpoint, instead leaning on earlier-stage efficacy signals and emerging combination data to support a potential path toward conditional approval.
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Blog Posts

  • Aug. 11, 2016
    By Mari Serebrov

    Will biosimilar carve-outs put R&D for older MAbs on ice?

  • Feb. 27, 2013
    By Mari Serebrov

    Omontys Recall Rings Alarm Over Biosimilars

  • Jan. 29, 2013
    By Mari Serebrov

    Don’t Call Them Generics!

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Authors

  • Mari Serebrov
  • Jihyun Kim
  • Tamra Sami
  • Randy Osborne
  • Brian Orelli
  • Katie Pfaff
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