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 December 2024
  • 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: December 19, 2024
    • Olezarsen 
    • Ionis Pharmaceuticals, Inc.
    • Olezarsen is an investigational RNA-targeted medicine for the treatment of adults with familial chylomicronemia syndrome (FCS).

  • PDUFA Date: December 20, 2024
    • Sotagliflozin (Zynquista™)
    • Lexicon Pharmaceuticals
    • Sotagliflozin is an adjunct to insulin for patients with type 1 diabetes (T1D) and mild-to-moderate chronic kidney disease (CKD).

  • PDUFA Date: December 20, 2024
    • Datopotamab deruxtecan
    • Daiichi Sankyo and AstraZeneca
    • For the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung cancer (NSCLC) who have received prior systemic therapies, including an EGFR-directed therapy.

  • PDUFA Date: December 22, 2024
    • Glepaglutide
    • Zealand Pharma
    • A long-acting GLP-2 analog, as a ready-to-use, fixed-dose product for subcutaneous delivery via an auto-injector for the treatment of short bowel syndrome (SBS).

  • PDUFA Date: December 26, 2024
    • Revumenib
    • Syndax Pharmaceuticals
    • revumenib) is a selective inhibitor of the menin-KMT2A interaction for the treatment of relapsed or refractory (R/R) acute leukemia, including those with KMT2Ar or mNPM1.

  • PDUFA Date: December 26, 2024
    • Imcivree (setmelanotide)
    • Rhythm Pharmaceuticals
    • To treat obesity because of Bardet-Biedl syndrome (BBS) or pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency obesity in children as young as 2 years old.

  • PDUFA Date: December 27, 2024
    • DCCR (diazoxide choline)
    • Soleno Therapeutics
    • For the treatment of hyperphagia in individuals with Prader-Willi syndrome (PWS).

  • PDUFA Date: December 28, 2024
    • Chenodiol
    • Mirum Pharmaceuticals, Inc.
    • For the treatment of cerebrotendinous xanthomatosis (CTX).

  • PDUFA Date: December 28, 2024
    • Ensartinib
    • Xcovery Holdings
    • Ensartinib is a next-generation oral tyrosine kinase inhibitor for the first-line treatment of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).

  • PDUFA Date: December 28, 2024
    • Cosibelimab
    • Checkpoint Therapeutics
    • Cosibelimab is a high-affinity programmed cell death-ligand 1 (PD-L1)-blocking antibody for the treatment of advanced cutaneous squamous cell carcinoma.

  • PDUFA Date: December 30, 2024
    • Crinecerfont
    • Neurocrine Biosciences, Inc.
    • Crinecerfont is a corticotropin-releasing factor type 1 receptor (CRF1R) antagonist developed to treat classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency (21OHD).

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