The study found that just 20% of trials submitted to both the FDA and European Medicines Agency had matching evidence.

Doron Therapeutics, a clinical-stage biotechnology company based in Chapel Hill, has received a Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration ...

Proportion increases when considering off-label use but drops when considering drugs with substantial clinical benefit.

Such tests are increasingly moving beyond their origins in cutting-edge research and into the laboratory and diagnostic ...

The FDA’s Oncologic Drugs Advisory Committee recently voted to narrow the label for checkpoint inhibitors Keytruda and Opdivo ...

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...

A study published in November in the American Journal of Clinical Pathology that Emerson co-authored validated the analyzer against the Sysmex XN Automated Hematology System and found that CytoChip's ...

After more than six years of development, Angle has scored an FDA approval for Parsortix as a ... by harvesting cells from a patient blood sample. In a statement, the UK medical device firm ...

Q4 2024 Earnings Call Transcript March 6, 2025 Phathom Pharmaceuticals, Inc. beats earnings expectations. Reported EPS is $-0 ...