An FDA safety alert warns that the antibiotic azithromycin (Zithromax, Zmax) should not be given long-term to prevent a certain inflammatory lung cond...
FDA grants PharmaMar an orphan drug designation for lurbinectedin and its use in treating small cell lung cancer.
FDA commissioner Scott Gottlieb says the agency is prioritizing its efforts to help product developers bring novel nicotine replacement therapy drugs ...
Federal Register notice: FDA submits to OMB an information collection extension for Medical Device Recall Authority (OMB Control Number 0910-0432).
FDA releases a guidance entitled: Medical Device User Fee Small Business Qualification and Certification.
Federal Register notice: FDA announces a 9/14 public workshop entitled Advancing the Development of Pediatric Therapeutics: Advancing Pediatric Pharma...
The Senate passes a minibus FY 2019 appropriations package that includes a $159 million (5%) boost for FDA over the FY 2018 enacted level.
Federal Register notice: FDA announces that it has revoked an Emergency Use Authorization issued to Zalgen Labs for the ReEBOV Antigen Rapid Test, int...