FDA releases the form FDA-483 issued following an inspection at the Little Rock, AR-based SCA Pharmaceuticals outsourcing facility.
Mercks Keytruda with concurrent chemoradiotherapy meets the progression-free survival primary endpoint in an interim analysis of the KEYSTONE A-18 cer...
FDA clears an Xstrahl 510(k) for its Radiant Aura treatment device for providing radiation therapy to non-melanoma skin cancer patients.
FDA grants Karyopharm Therapeutics fast track status for selinexor for treating patients with myelofibrosis.
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...
