The OVATION-3 trial is designed to provide an early readout in HRD and BRCA1/2-mutated ovarian cancer patients, ideally leading to rapid filing and approval.

The regulator is allowing the firm to submit data on 4D-150 from a single Phase III trial and draw on readouts from previously conducted studies in wet AMD.

In a retrospective analysis of patients who received peptide vaccines via n-of-1 programs, 89 percent had immune reactions.

The FDA granted priority review to the application and will decide whether to approve the treatment by Dec. 5.

Under Project Impact, one of four programs backed by $200 million in funds, researchers aim to harmonize EHR data and build an AI model to improve cancer care.