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Most of its precision oncology products, including Lorbrena, Braftovi, Mektovi, and Talzenna, posted double-digit increases ...
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.
If a progression-free survival readout later this year is positive, the firm will pursue approval in HLA-A2-negative metastatic uveal melanoma.
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.
The FDA granted priority review to the application and will decide whether to approve the treatment by Dec. 5.
In a retrospective analysis of patients who received peptide vaccines via n-of-1 programs, 89 percent had immune reactions.