The Sedgwick third quarter 2024 recall index documents an increase in medical device recalls and a decrease in drug recalls.
FDA grants SonoMotion a de novo marketing authorization for its Stone Clear device for the ultrasound treatment of post-lithotripsy kidney stone fragm...
FDA cautions Merz over misleading representations about its Xeomin in a promotional piece featuring celebrity spokesman Nate Berkus.
Philips Respironics recalls (Class 1) its Garbin Evo ventilators due to the potential for aerosol deposit accumulation on the devices internal flow se...
Two stakeholder trade associations suggest changes to an FDA strategy document on innovative manufacturing technologies.
President-elect Donald Trump picks controversial FDA critic and vaccine skeptic Robert F. Kennedy Jr. as his secretary for Health and Human Services.
Adaptimmune Therapeutics plans a rolling BLA submission for cell therapy lete-cel in certain people with synovial sarcoma or myxoid/round cell liposar...
FDA releases the form FDA-483 with seven observations from an inspection at the U.S. Specialty Formulations outsourcing facility in Allentown, PA.
