Pfizer has announced its new digital platform — PfizerForAll — which will partner with a network of healthcare organizations to help patients find and access care, fill prescriptions and find…
This edition of Quick Notes features FDA’s approval of implantation of Medtronic’s neurostimulators for deep brain stimulation in sleeping patients, a De Novo clearance for SoClean’s bacterial reduction system for…
The Biden Administration has announced up to $150 million in Advanced Research Projects Agency for Health (ARPA-H) awards to develop technologies that will allow surgeons to provide more successful tumor-removal…
In recalls the FDA describes as the most serious type, Inari Medical is updating its directions for use of its ClotTriever XL catheter and Medline is warning against use of…
During the second session of the 118th Congress, FDAnews will track important pending legislation, that has been acted on by Dec. 31, 2023 to keep you updated on laws and…
This edition of Quick Notes features announcements of Baxter’s agreement to sell its Vantive Kidney care segment, Merck’s B-Cell depletion therapy acquisition, Triastek collaboration with BioNTech and Crown Laboratories and…
Debfitech has issued an urgent medical device safety removal letter to its customers of the RMU-2000 ARM XR chest compression device, which provides chest compressions on adults whose hearts suddenly…
Citing ethical and data concerns, four US lawmakers have begun an investigation into clinical research conducted jointly by American biopharma firms and the Chinese military, as well as trials run…
This week, the FDA published final guidance on product-specific guidance meetings between FDA and ANDA applicants and an electronic submission template for medical device de novo requests. Draft guidance was…
In this edition of Quick Notes EU, we note a revised EMA guideline on pharmacovigilance, a call by EMA to revoke authorization of Ocaliva for treatment of primary biliary cholangitis…