Medtronic recalls its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators with glassed feedthrough due to a p...
Olympus recalls about 1,500 OES BronchoFiberscope BF Type devices after receiving complaints of endobronchial combustion during therapeutic laser proc...
Four drug stakeholders suggest changes to a draft FDA guidance on scientific considerations in pediatric drug development.
A Government Accountability Office report on the challenges of regenerative medicine therapies and technologies offers 11 policy options to be conside...
FDA accepts for review an Elevar Therapeutics NDA for rivoceranib, an oral tyrosine kinase inhibitor in combination with camrelizumab, a PD-1 inhibito...
FDA warns Mumbai, India-based Centaur Pharmaceuticals about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
FDA warns San Jose, CA-based Outset Medical it is illegally marketing two medical devices associated with hemodialysis.
FDA gives Catalent a four-page Form FDA-483 after inspecting the firms Bloomington, IN manufacturing facility 5/4-12.
