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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.
The firm will continue developing Lava's two partnered bispecific gamma delta T-cell engager programs with Pfizer and Johnson & Johnson.
The firm will evaluate the drug's safety and early efficacy in patients with advanced AKT1 E17K-mutant solid tumors.
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.
BioCardia wants to gauge whether it has enough evidence to pursue regulatory approval for CardiAMP in ischemic heart failure.
At AAIC, Lilly highlighted benefits of being able to stop Kisunla, while Eisai made a case for subcutaneous Leqembi, which is ...
Neurologists from multiple clinics shared data at AAIC on the Alzheimer's drug's use, shedding light on its safety and ...
Experts don't back specific tests, but provide guidelines on how doctors in specialty care settings can use them to diagnose ...
The platform will support Anocca's Phase I/II trial of its therapies under development for treating KRAS-mutated pancreatic cancer.