FDA grants Valar Labs a breakthrough device designation for its Vesta Bladder Risk Stratify Dx test.
FDA approves Guardant Healths next-generation Guardant360 Liquid CDx, a blood-based comprehensive genomic profiling test designed to provide both geno...
FDA accepts for review an ImmunityBio supplemental BLA seeking to expand the label for Anktiva (nogapendekin alfa inbakicept-pmln) in combination with...
FDA warns Chinas Hangzhou Yiqi Biotechnology Co. about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
FDA publishes frequently asked questions covering eligibility, statement of interest, and selection of participants for the TEMPO digital health pilot...
FDA warns Chinas Harbin Jixianglong Biotech about CGMP deviations and other violations in its manufacturing of active pharmaceutical ingredients.
A Stanford Law School Center for the Law and Biosciences fellow says policymakers should consider the growth in breakthrough medical devices cleared t...
FDA grants Bayer a priority review for its NDA for asundexian, an investigational oral Factor XIa inhibitor designed to reduce the risk of recurrent s...
