Federal Register notice: FDA seeks comments on an information collection extension entitled Biologics License Applications Procedures and Requirements...
FDA posts a draft guidance on recommendations for measuring and recording growth, and evaluating pubertal development for evaluating safety in pediatr...
Federal Register notice: FDA seeks comments on an information collection extension entitled Special Protocol Assessment.
Bristol Myers Squibb reports that its COMMANDS Phase 3 study evaluating Reblozyl (luspatercept-aamt) met its primary endpoint in first-line treatment ...
FDA recommends that health care providers discuss alternative magnetic resonance imaging-guided breast biopsy options with patients if facilities are ...
FDA alerts patients and health care providers about a shortage of tracheostomy tubes, including Bivona tracheostomy tubes manufactured by ICU Medical....
FDA issues Gilead a complete response letter on its BLA for bulevirtide, an investigational entry-inhibitor for treating adults with hepatitis delta v...
Federal Register notice: FDA makes available a draft guidance entitled Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction o...
