In this edition of Quick Notes EU, we note a new EMA guidance on treating exposure to chemical agents used as weapons, the UK’s decision to offer Vertex’s gene editing…

This excerpt is from the management report titled “Using Real-World Evidence in Drug and Device Submissions,” based on a webinar from FDAnews, A WCG Company. The presenters were Kristin Zielinski…

Failure to conduct complete testing on sterile injectables, falsified monitoring records of areas used for aseptic filling lines as well as falsified cleaning records are among the serious lapses documented…

Regeneron Pharmaceuticals has confirmed that the FDA will not make a decision on approving its investigational multiple myeloma drug linvoseltamab for at least the next few months, citing problems encountered…

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…