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Precision Oncology Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

BBT-176, a novel agent designed to inhibit EGFR with C797S mutations, will start first-in-human studies in NSCLC this year.

AstraZeneca and Merck also announced they have filed for approval of Lynparza in patients who have mutations in more than a dozen homologous recombination repair genes.

Increasing understanding of complex tumor biology is reshaping clinical trials in the age of precision medicine, though some view these changes with concern.

Puma provided an update on its plan for Nerlynx and Natera discussed the cancer trials its Signatera test is being used in.

The FDA granted priority review status to rucaparib for prostate cancer patients with BRCA1/2 mutations.