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FDA grants Valar Labs a breakthrough device designation for its Vesta Bladder Risk Stratify Dx test.[ Price : $8.95]
FDA approves Guardant Healths next-generation Guardant360 Liquid CDx, a blood-based comprehensive genomic profiling test designed ...[ Price : $8.95]
FDA accepts for review an ImmunityBio supplemental BLA seeking to expand the label for Anktiva (nogapendekin alfa inbakicept-pmln)...[ Price : $8.95]
FDA warns Chinas Hangzhou Yiqi Biotechnology Co. about CGMP deviations in its manufacturing of active pharmaceutical ingredients.[ Price : $8.95]
FDA publishes frequently asked questions covering eligibility, statement of interest, and selection of participants for the TEMPO ...[ Price : $8.95]
FDA warns Chinas Harbin Jixianglong Biotech about CGMP deviations and other violations in its manufacturing of active pharmaceutic...[ Price : $8.95]
A Stanford Law School Center for the Law and Biosciences fellow says policymakers should consider the growth in breakthrough medic...[ Price : $8.95]
FDA grants Bayer a priority review for its NDA for asundexian, an investigational oral Factor XIa inhibitor designed to reduce the...