FDA makes available a guidance on formal meetings between FDA and sponsors or applicants of biosimilar products.
Hospira recalls two lots of naloxone hydrochloride injection, 0.4 mg/mL, 1 mL in 2.5 mL in its Carpuject single-use cartridge syringe system due to th...
FDA alerts health care providers about five additional deaths associated with the use of liquid-filled intragastric balloon devices for obesity treatm...
FDA clears a Micronics 510(k) for its PanNAT STEC Test and its use in detecting Shiga toxin-producing E. coli.
FDA Review posts the Federal Register notices for the week ending 6/1/2018.
FDA clears a Medicrea Group 510(k) for patient-specific spinal cages through the extension of its UNiD ASI (Adaptive Spine Intelligence) technology to...
FDA approves an Eli Lilly and Incyte NDA for Olumiant (baricitinib 2mg), a once-daily oral drug for treating adults with moderately-to-severely active...