The Food and Drug Administration (FDA) protects public health by guaranteeing the safety, effectiveness, and security of pharmaceuticals and medical devices. The Prescription Drug User Fee Act (PDUFA) date marks the deadline by which the FDA must complete its review of drug applications. Occasionally, an advisory committee (AdCom) meeting is convened to assess the drug or device under consideration. Presented below is a comprehensive list of drugs and devices, along with the anticipated decision date.

Upcoming FDA Decisions for November 2024
  • AdCom Meeting Date: November 7, 2024
    • ProSense Cryoablation System
    • IceCure Medical Ltd.
    • The discussion will focus on the sponsor’s proposed indication:  “for use in the treatment of patients with early stage, low-risk breast cancer for the treatment of breast cancer with adjuvant endocrine therapy.”

  • AdCom Meeting Date: November 21, 2024
    • Andexxa
    • AstraZeneca
    • The committee will discuss the supplemental biologics license application (sBLA) 125586/546 from AstraZeneca for Andexxa (coagulation factor Xa (recombinant), inactivated -zhzo), for patients treated with rivaroxaban or apixaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

  • PDUFA Date: November 4, 2024
    • DFD-29
    • Journey Medical Corporation
    • It is a low-dose, modified-release capsule formulation of minocycline for the treatment of inflammatory lesions and erythema of rosacea in adults.

  • PDUFA Date: November 13, 2024
    • Eladocagene Exuparvovec
    • PTC Therapeutics, Inc.
    • It is a gene replacement therapy for use in the treatment of aromatic L-amino acid decarboxylase (AADC) deficiency.

  • PDUFA Date: November 16, 2024
    • Obecabtagene autoleucel (obe-cel)
    • Autolus Therapeutics
    • For the treatment of adult patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (ALL).

  • PDUFA Date: November 28, 2024
    • Govorestat 
    • Applied Therapeutics
    • It is a central nervous system penetrant Aldose Reductase Inhibitor (ARI) in development for the treatment of galactosemia.

  • PDUFA Date: November 29, 2024
    • Acoramidis
    • BridgeBio Pharma, Inc.
    • For the treatment of patients with transthyretin amyloid cardiomyopathy [ATTR-CM].

  • PDUFA Date: November 29, 2024
    • Zanidatamab
    • Jazz Pharmaceuticals plc
    • It is a biparatopic HER2-targeted bispecific antibody for previously-treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC).

  • PDUFA Date: November 30, 2024
    • SH-201
    • Shorla Oncology
    • It is the first palatable oral liquid of the related chemotherapeutic agent to treat various types of cancers.

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