FDA clears Spineology 510(k) for its Rampart One Standard ALIF interbody fusion system for use with or without supplemental fixation.
FDA approves Mylans Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Amgens Neulasta (pegfilgrastim) to decrease the chance of infection as su...
Federal Register notice: FDA issues a proposed order to reclassify medical image analyzers applied to mammography breast cancer, ultrasound breast les...
Federal Register notice: FDA makes available a draft guidance entitled Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clini...
CDER director Janet Woodcock proposes changes to her Centers new drug regulatory program that are intended to free up resources so staff can focus on ...
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...