Drug Approval | January 14, 2026
Camurus’ Oclaiz NDA resubmission accepted by FDA
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026
The investigational subcutaneous hepcidin mimetic peptide is designed to regulate iron and red blood cell production
The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer
The applications aim to launch Phase Ib/II trials for relapsed/refractory multiple myeloma and primary plasma cell leukemia, respectively
If approved, imlifidase has the potential to transform the kidney transplant landscape by enabling highly sensitized patients to also have access to a potentially life-changing kidney transplant
If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease
Presbyopia, the age-related loss of near vision, could soon be treated successfully
Pioneering innovation aims to transform anticoagulant therapy and improve patient outcomes
Marks first international filing for Evofem’s single-dose oral treatment
The NDA submission follows the successful completion of a pivotal Phase III global clinical trial
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