The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy
Grangemouth serves as PPS’s dedicated antibody-drug conjugate development and manufacturing hub
The patent will lock in broad protection for the company’s lead therapy CardiolRx and its novel subcutaneous candidate CRD-38
This marks Lupin’s first commercial product leveraging PrecisionSphere, a proprietary long-acting injectable (LAI) technology
The observations are procedural in nature and will be responded to within the stipulated time
The said inspection concluded with Zero Form 483 observation
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025
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