The agency converted a prior accelerated approval to a traditional approval based on results from the LIBRETTO-531 trial.

Researchers are planning a clinical trial after four metastatic FGFR2 fusion-positive pancreatic cancer patients responded to ...

The agency is considering whether to limit the indications of Keytruda, Opdivo, and Tevimbra to PD-L1-positive patients amid testing uncertainties.

Researchers hope DeepGEM can expedite targeted treatment for lung cancer patients who can't access standard genomic testing.

The Florida-based provider will work with AI software company AiraMed to analyze and measure patients' brain volume from MRIs.

NEW YORK – 858 Therapeutics on Thursday said it raised $50 million in a Series B financing round to advance its pipeline of small molecule therapeutics, including the poly (ADP) ribose glycohydrolase ...

The third-generation EGFR inhibitor will now be an option for patients whose tumors are not metastatic but can't be removed with surgery.

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 ...