Federal Register notice: FDA requests nominations for voting members to serve on CDRHs National Mammography Quality Assurance Advisory Committee.
FDA extends by three months the review of a Genentech supplemental BLA for Tecentriq (atezolizumab) for use in combination with Avastin (bevacizumab),...
Federal Register notice: FDA makes available a draft guidance entitled Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live M...
FDA approves labeling changes for three ViiV HIV drugs containing dolutegravir to address risk of neural tube defects.
A California federal court dismisses PhRMAs suit against a state drug pricing transparency law and gives the association an opportunity to amend its c...
FDA clears a Surgical Innovation Associates 510(k) for DuraSorb Monofilament Mesh, a line of advanced bioabsorbable technologies for reconstructive an...
FDA says it will continue to monitor research into quantifying live microbial dietary ingredients in probiotics rather than approve a petition seeking...
FDA commissioner Scott Gottlieb announces a revised memorandum of understanding to be signed with states that want to collaborate with the agency in i...