Federal Register notice: FDA announces the approval of product that redeemed a priority review voucher AstraZencas sBLA for Ultomiris (ravulizumab-cw...
FDA says the GE Healthcare recall of its Carescape R 860 ventilator due to issues with its backup and replacement backup batteries is Class 1.
FDA releases an FDA-483 with six observations from an inspection at Lake Balboa, CA-based Expert Compounding Pharmacy, a producer of non-sterile drugs...
FDA updates activities in the Digital Health Center of Excellence.
CDER Office of Surveillance and Epidemiology staffer Oanh Dang explains how drug safety analysts are using an information visualization platform to ea...
FDA announces two new pilot programs that the International Coalition of Medicines Regulatory Authorities (ICMRA), of which the agency is a member, is...
Gilead Sciences refiles an NDA for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for treating HIV-1 infection in heavily treatm...
FDAs Vaccines and Related Biological Products Advisory Committee votes 19 to 2 to recommend that the SARS-CoV-2 strain composition of Covid-19 vaccine...