A Roche Phase 3 study called COMMODORE 2 that was evaluating the efficacy and safety of crovalimab in certain people with paroxysmal nocturnal hemoglo...
FDA proposes an advisory committee-led hearing to address a CDER 2021 decision not to approve an NDA submitted by Intarcia Therapeutics for ITCA 650 (...
FDA warns Alajuela, Costa Rica-based MicroVention Costa Rica about Quality System regulation violations in the manufacture of microcatheters and ballo...
FDA warns Nendingen, Germany-based Getsch+Hiller Medizintechnik about Quality System violations in its production of adulterated and misbranded monopo...
Federal Register notice: FDA seeks comments on an information collection extension entitled FDA Administrative Practices and Procedures; Formal Hearin...
FDA revises its online guide on when and how often people should use an over-the-counter at-home Covid-19 test to encourage users to self-report their...
FDA approves a Takeda supplemental BLA for an expanded use of Takhzyro (lanadelumab-flyo) prophylaxis to prevent attacks of hereditary angioedema in ...
Federal Register notice: FDA determines that 31 drug products were not withdrawn from sale due to safety or effectiveness reasons.
