The agency's acceptance was based on results from the Phase III OptiTROP-Lung05 study, which met its primary endpoint of progression-free survival.

The FDA granted a Commissioner's National Priority Voucher to accelerate the review of the treatment, which was submitted for approval last month.

The company looked externally for cell therapy and ADC additions to its pipeline last quarter, keeping internal R&D spending ...

The firm will focus on encouraging physicians to prescribe the combination therapy for ovarian cancer patients at first recurrence.

The FDA has extended the review period for its supplemental biologics license application of Leqembi Iqlik by three months to Aug. 24.

InVimmune will first focus development efforts in oncology, where the firms say unmet need remains high. To that end, the company has established an oncology scientific advisory board that includes ...

Institutions' precision medicine programs are maturing, facing new questions about how AI will change clinical decision ...