Vonvendi is the only recombinant Von Willebrand factor replacement therapy with approved indications in adults and children with VWD
Based on the CRL, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population
Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy
This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.
This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting
The safety profile of the Lunsumio and Polivy combination was consistent with the known profiles of the individual study medicines
The FDA has granted Priority Review, setting a target decision date of 9 October 2026, potentially accelerating access to a new treatment option for a subset of patients with high-risk colon cancer characterized
ILUMYA has already earned FDA approvals for scalp and nail plaque psoriasis in April 2024 and December 2025
Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
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