A Kleinfeld, Kaplan & Becker online post predicts that the prolonged Covid-19 pandemic will likely see the agency continue to adapt and utilize new st...
Two MedHealth influencers say the health community must find ways to expand the use of real-world data in clinical trials.
CBER Office of Tissues and Advanced Therapies director Wilson Bryan says the office is swamped with new product submissions to the extent that it is c...
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...