FDA grants Anumana a breakthrough device designation for its ECG-AI algorithm for detecting cardiac amyloidosis.
FDA commissioner Robert Califf says the agency needs to get in front of regulating large language models using ChatGPT that could be used in medical d...
Two Brookings Institution fellows suggest three steps to address the shortage of generic sterile injectable drugs.
FDA grants full approval to Amgens previously accelerated-approved BLA for Blincyto (blinatumomab) for treating certain adults and pediatric patients ...
FDA launches a pilot program to post laboratory-developed test performance information using biomarkers to help facilitate better cancer drug selectio...
FDA issues F2G Ltd. a complete response letter on its NDA for olorofim, an antifungal for invasive fungal infections in patients who have limited or n...
FDA warns Tustin, CA-based Vitang Technology that its UniSmile Dental Aligner is misbranded and adulterated and thus is being sold illegally.
FDA issues a clinical hold on Arcellxs CART-ddBCMA for treating patients with relapsed or refractory multiple myeloma, after a recent patient death wa...
