The ODAC will weigh risk-benefit analyses from the FDA and sponsors on Keytruda, Opdivo, and Tevimbra when given with chemo in all comers and in PD-L1-positive subgroups.
The collaboration will focus on identifying protein biomarkers associated with immunotherapy response across cancer types.
NEW YORK – Bristol Myers Squibb and 2seventy bio said on Wednesday they are discontinuing enrollment in the Phase III KarMMa-9 study evaluating maintenance treatment with CAR T-cel therapy Abecma ...
As part of the deal, the companies said they will work together to advance gene therapies for diseases with high unmet medical need.
In a report, a working group cautioned that the program must lessen its reliance on congressional appropriations or risk ...
The firm will evaluate the engineered cell therapy in patients with melanoma, and non-small cell lung, head and neck, colorectal, pancreatic, and cervical cancer.
The Italian firm aims to bring its lead candidate, Aptadir Ce-49, into clinical trials for myelodysplastic syndrome next year.
The company said it expects this restructuring plan to result in its quarterly cash flow breaking even by the second half of next year.
During a panel discussion at the National Society of Genetic Counselors meeting, genetic counselors discuss the risks and benefits of gene therapies.
Despite showing a progression-free survival benefit, the antibody-drug conjugate did not improve overall survival in HR-positive, HER2-negative or -low breast cancer.
The European Commission approval was based on two Phase III trials showing Vyloy plus chemo improved survival outcomes versus chemo alone.
NEW YORK – Sensorion on Monday said that by year end it expects to complete dosing the first cohort of pediatric patients with congenital hearing loss with its gene therapy candidate SENS-501 in the ...