Purpose: The revised prescription drug labeling developed by the Food and Drug Administration (FDA) is described. Summary: A new FDA final rule, "Requirements on Content and Format of Labeling for ...
Bristol-Myers Squibb has claimed FDA approval for a new, tumour-agnostic indication for Augtyro, the cancer drug it acquired as ... has now had its label extended to include all solid tumours ...
A separate section on patient-counseling information has been added in response to the requirement that all FDA-approved patient information be reprinted in or accompany drug product labeling.