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.

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.

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.

The firm will evaluate the drug's safety and early efficacy in patients with advanced AKT1 E17K-mutant solid tumors.

The firm will continue developing Lava's two partnered bispecific gamma delta T-cell engager programs with Pfizer and Johnson & Johnson.

BioCardia wants to gauge whether it has enough evidence to pursue regulatory approval for CardiAMP in ischemic heart failure.

The financing will in part support development of the firm's PI3K inhibitor paxalisib in PIK3CA-mutated brain cancer and HER2-positive breast cancer.

This month, the firm also performed a 1-for-15 reverse share split to maintain compliance with Nasdaq listing requirements.

Sanofi will acquire rights to develop and commercialize the drug for $130 million upfront, with Visirna eligible for up to $265 million in milestone payments.

At AAIC, Lilly highlighted benefits of being able to stop Kisunla, while Eisai made a case for subcutaneous Leqembi, which is ...