The FDA released a much-anticipated draft guidance on how makers of rare disease genetic medicines can leverage a platform ...

Phase III data show the Braftovi regimen significantly improves overall survival and response versus chemo as a frontline treatment for advanced tumors.

NEW YORK – The European Commission on Monday approved Johnson & Johnson's subcutaneous Rybrevant (amivantamab) in two new dosing schedules as a first-line treatment for patients with advanced ...

Regenxbio and the trustees of UPenn in 2020 filed a patent infringement lawsuit alleging Sarepta was illegally using patented tech in its Duchenne gene therapy.

Researchers are evaluating the P-CARE model, which integrates results from a blended genome-exome sequencing assay and family ...

In a study with three UK academic institutions, the platform agreed with MDx results 94 percent of the time in detecting ...

The FDA also accepted Gilead's BLA seeking the cell therapy's approval in multiple myeloma and will decide whether to approve it by December.

The FDA granted priority review to the BLA for DTX401 and is expected to announce its decision by late August.

The gene therapy, which was acquired by Novartis in 2023, is also being tested in a separate Phase I/II trial of pediatric ...

The company is expecting additional readouts this year from studies of cancer vaccine intismeran autogene, which is being tested in late-stage trials.

A study evaluated agreement between 10 AI digital pathology tools in assessing IHC-based HER2 expression and found the most variability in identifying HER2-low samples.

The driving force behind the lab was a desire to control biomarker discovery, streamline regulatory approvals for CDx, and develop drugs more cheaply and quickly.