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Day One Biopharmaceuticals, LLC

https://dayonebio.com/

Latest From Day One Biopharmaceuticals, LLC

Keeping Track: Two Breakthrough Oncologics, Another Antibiotic Clear US FDA Along With Pfizer’s Hemophilia B Gene Therapy

The US FDA approved Day One’s pediatric brain cancer drug Ojemda, ImmunityBio’s bladder cancer immunotherapy Anktiva, an uncomplicated UTI claim for Utility Therapeutics’ Pivya, which has a long history in Europe, and Pfizer’s hemophilia B gene therapy Beqvez.

US FDA Performance Tracker Approvals

Day One Springs Into Commercial Action With Ojemda Approval

The company is targeting around 200 centers that treat the vast majority of the few thousand pediatric low-grade glioma patients who are candidates for the RAF-targeting drug.

Approvals Cancer

Glioblastoma Market Snapshot: Two Approvals In 2024 And A Rich Pipeline

Glioblastoma carries a grim prognosis. The biopharma industry is trying to improve patient outcomes, with 120 drugs in the pipeline and two anticipated approvals this year.

Market Intelligence Market Snapshot

US FDA’s April Outlook: Decisions Pending For Rare Pediatric Diseases, New Antibiotics

User fee goal dates in April include four novel agents with breakthrough therapy designations, including Pfizer’s hemophilia B gene therapy and Immunity Bio’s IL-15 superagonist complex for bladder cancer.

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Company Information

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  • Biotechnology
  • Pharmaceuticals
  • Other Names / Subsidiaries
    • DOT Therapeutics-1, Inc.
    • DOT-1
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