FDA clears a YorLabs 510(k) for its new intracardiac imaging system that the company says could reshape workflows in catheterization labs.
FDA posts a seven-item Form FDA-483 after inspecting Dr. Reddys Mirfield, West Yorkshire, UK, active pharmaceutical ingredient manufacturing facility ...
Intellia Therapeutics pauses two Phase 3 trials of nex-z, a CRISPR-based therapy for transthyretin amyloidosis with cardiomyopathy and polyneuropathy,...
A Senate Committee demands answers from HHS on what they describe as serious national security and public health risks tied to Americas dependence on ...
FDA sends Sydnexis a complete response letter for SYD-101, a low-dose atropine eye-drop candidate intended to slow disease progression in children wit...
FDA grants Partner Therapeutics a breakthrough therapy designation for zenocutuzumab-zbco and its use in treating cholangiocarcinoma defined by NRG1 g...
Inhibrx Biosciences reports favorable data for treating chondrosarcoma with its antibody therapy ozekibart (INBRX-109).
FDA posts a two-item Form FDA-483 from an August inspection of Sumitomo Pharmas Suzuka, Japan, manufacturing facility.
