Dostarlimab-gxly demonstrated high rates of sustained clinical complete response that allowed eligible patients to avoid chemotherapy, radiation, and surgery.
The application for the next-generation mitomycin formulation is supported by 3-month complete response data from the phase 3 UTOPIA trial.
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for rezafungin (Rezzayo ®) for the prophylaxis of invasive fungal disease.
The Food and Drug Administration (FDA) has expanded the approval of Ryzumvi ® (phentolamine ophthalmic solution 0.75%) to include the treatment of presbyopia in adults.