FDA and Oncolytics Biotech agree on a special protocol assessment for a Phase 3 trial of the companys Reolysin to treat metastatic breast cancer.
FDA files two federal court complaints seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA appro...
Federal Register notice. FDA makes available a guidance entitled S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposur...
FDA denies without comment a Mylan petition asking it to impose conditions on approval of any ANDA citing Advair Diskus as the reference-listed drug.
FDA grants Sellas Life Sciences Group an orphan drug designation for its novel drug candidate, galinpepimut-S, for treating multiple myeloma.
Federal Register notice: FDA makes available a draft guidance entitled Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment.
FDA asks drug applicants to use SNOMED CT to characterize disease names for product indications.
FDA approves an Astellas Pharma supplemental NDA that seeks approval for the use of mirabegron in combination with solifenacin succinate 5 mg for trea...