The CDER Office of Translational Sciences 2022 annual report lists what it says were achievements in five areas of activity.
Bipartisan leaders of the House Energy and Commerce Committee express concerns about FDA foreign inspections and ask for answers to 22 questions.
Akebia Therapeutics completes an End of Dispute Type A meeting with FDA that discussed the companys upcoming NDA resubmission for vadadustat as a trea...
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...
