Reps. Eric Sorensen and Stephanie Bice introduce bipartisan legislation to allow FDA to deny so-called sham citizen petitions filed by drug companies ...
Implantica files the final response to FDA on its PMA for RefluxStop that addresses the agencys remaining questions tied to Module 3 of the device for...
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.
