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 or device applications. Below, you will find a list of drugs and devices, as well as their anticipated approval dates.
Anticipated Approvals for May 2024
PDUFA Date: May 14, 2024
TransCon PTH
Ascendis Pharma
An investigational prodrug of parathyroid hormone (PTH [1-34]) for adult patients with hypoparathyroidism.
PDUFA Date: May 16, 2024
Rivoceranib plus camrelizumab
Elevar Therapeutics, Inc.
An oral TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line treatment option for unresectable hepatocellular carcinoma (uHCC).
PDUFA Date: May 23, 2024
Lisocabtagene maraleucel (Brezanzi®)
Bristol Myers Squibb
Expanding into new indications to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).
PDUFA Date: May 25, 2024
Prademagene zamikeracel
Abeona Therapeutics Inc.
An investigational autologous, COL7A1 gene-corrected epidermal sheets, is currently being developed for the treatment of recessive dystrophic epidermolysis bullosa (RDEB).
PDUFA Date: May 31, 2024
Lisocabtagene maraleucel (Brezanzi®)
Bristol Myers Squibb
Expanding into new indications to include the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after a Bruton tyrosine kinase inhibitor (BTKi).
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