FDA grants Mereo BioPharma Group fast track status for navicixizumab and its use for treating high grade ovarian, primary peritoneal or fallopian tube...
FDA clears a ProTom International Holding 510(k) for its Radiance 330 proton therapy system.
FDA Review posts the Federal Register notices for the week ending 10/4/2019.
FDA Review posts product approval summaries for the week ending 10/4/2019.
Federal Register notice: FDA announces an 11/13 Endocrinologic and Metabolic Drugs Advisory Committee meeting to review a Boehringer Ingelheim supplem...
As part of FDAs Safe Use Initiative, CDER director Janet Woodcock announces a funding opportunity for individuals and organizations to conduct further...
FDA updates a consumer alert to warn against using vaping products containing THC as the latest number of reported cases and deaths associated with va...
FDA accepts for review a DBV Technologies BLA for its investigational Viaskin peanut immunotherapy for treating peanut-allergic children ages four to ...