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NEWS & INSIGHTS

Dive into the Biopharma Space

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4 days ago1 min read

4 Companies with FDA Approval Decisions Expected Before the End of January

We used our biopharmIQ online platform to identify upcoming FDA approval (PDUFA) dates for biopharma companies through the end of January 2025. See the below for more info on these upcoming PDUFA dates.


Check out our free PDUFA calendar for info re: all upcoming PDUFAs in 2025.


These 4 companies have FDA final approval decision (PDUFA) dates before the end of January:


Atara Biotherapeutics

  • Drug/Therapy: Tab-cel (tabelecleucel)

    • Allogeneic T-cell immunotherapy

  • Indication: Post-Transplant Lymphoproliferative Disease (PTLD)

  • PDUFA date: January 15, 2025

  • BLA with priority review


Biogen

  • Drug/Therapy: Leqembi (Lecanemab) IV Maintenance Dosing

    • Amyloid beta-directed antibody

  • Indication: Early Alzheimer’s Disease

  • PDUFA date: January 25, 2025

  • sBLA


Vertex Pharmaceuticals

  • Drug/Therapy: Suzetrigine (VX-548)

    • Non-opioid pain signal inhibitor

  • Indication: Moderate-to-severe acute pain

  • PDUFA date: January 30, 2025

  • NDA with priority review


Axsome Therapeutics

  • Drug/Therapy: AXS-07 (MoSEICâ„¢ meloxicam and rizatriptan)

    • NSAID & 5-HT1B/1D agonist combination

  • Indication: Migraine

  • PDUFA date: January 31, 2025

  • Resubmitted NDA


See table below 📸👇


FIG 1. PDUFA Approvals expected before the end of January.


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Article History:

AV/MV/RF/DG (1/9/25)


Not legal, investing, or tax advice.

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