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.
Memory Treatment Centers to Study Brain Volume Changes in Alzheimer's Patients on Anti-Amyloid Drugs
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.
NEW YORK – ReCode Therapeutics on Thursday said it has treated the first cystic fibrosis patient with its inhaled messenger RNA (mRNA) therapy within a Phase Ib trial. Investigators will assess the ...
FDA Expert Panel to Consider Limiting Gastric, Esophageal Cancer Immunotherapies to PD-L1 Expressors
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.
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