Smiths Medical recalls specific lots of its BLUSelect, BLUgriggs, and BLUperc products due to a manufacturing defect.
PhRMA and USP recommend that FDA develop product class-specific guidances rather than product-specific guidances to spur the development of new biosim...
Federal Register notice: FDA announces a 12/4 Pharmacy Compounding Advisory Committee meeting to discuss various bulk drug substances being considered...
Intellia Therapeutics reports positive data from the ongoing Phase 1/2 study of NTLA-2002, a CRISPR-based gene editing therapy, in patients with hered...
The Public Citizen Health Research Group calls for a federal investigation into clinical trials for two Alzheimers drugs that may have violated inform...
Baxter Healthcare recalls (Class 1) its Life2000 ventilator to update the use instructions after finding that the device may fail to issue a low gas p...
Pfizer submits pages of recommended changes to an FDA draft guidance on incorporating voluntary patient preference information over a medical devices ...
Researchers from Case Western Reserve University School of Medicine report that semaglutide may reduce the risk of Alzheimer's disease in people with ...
