Three Akin attorneys say regulated industry continues to have questions about FDA actions in launching an internal artificial intelligence tool and ap...
FDAs Oncologic Drugs Advisory Committee votes against approving GSKs BLA for Blenrep (belantamab mafodotin) for treating adults with multiple myeloma ...
Dexcom recalls certain Dexcom G6, G7, ONE, and ONE+ glucose monitoring receivers because a speaker problem may prevent an alert from sounding.
Sen. Marsha Blackburn and Tennessee attorney general Jonathan Skrmetti call on the Federal Trade Commission to open an investigation into what they sa...
FDA warns Boston, MA-based Whoop that it is illegally marketing an unapproved medical device that estimates blood pressure, despite being cautioned by...
A Phase 3 clinical trial evaluating Alexions anselamimab for light chain amyloidosis fails to meet its primary endpoint, but shows significant clinica...
FDA releases a funding opportunity for natural history studies to advance product development in rare diseases and conditions.
FDA releases the form FDA-483 with seven observations from an inspection at Indias Natco Pharma.
