Former FDA commissioner Stephen Hahn is named CEO of Harbinger Health.
Federal Register notice: FDA seeks industry organizations interested in participating in selecting nonvoting industry representatives to serve on CDRH...
An FDA-ordered drug class warning begins appearing in labels of Janus kinase (JAK) inhibitors Pfizers Xeljanz (tofacitinib), Eli Lillys Olumiant (bar...
FDA grants RefleXion Medical a breakthrough device designation for its biology-guided radiotherapy for use in treating lung tumors.
FDA approves Mercks Keytruda (pembrolizumab) for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage 2B or 2C melan...
FDA approves Genentechs Rituxan (rituximab) in combination with chemotherapy for pediatric patients with previously untreated, advanced stage, CD20-po...
Ahead of a 12/8 FDA advisory committee meeting, agency reviewers cast doubt on the effectiveness of Reata Pharmaceuticals bardoxolone to slow the loss...
Theratechnologies files a supplemental BLA for Trogarzo (ibalizumab-uiyk) and an intravenous push form of administration for treating HIV-1 in combina...