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Federal Register notice: FDA makes available a draft guidance entitled Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction o...
Federal Register notice: FDA posts notifications that four information collections have been approved by OMB.
FDA relaxes advertising and promotion restrictions placed on six Covid-19 emergency use authorizations.
FDA posts a seven-item Form FDA-483 from an inspection of New England Life Care (dba Advanced Compounding Solutions) earlier this year.
An FDA advisory committee unanimously votes to not recommend approval of a Y-mAbs Therapeutics BLA for I-omburtamab.
