Oramed Pharmaceuticals discontinues clinical development of its Type 2 diabetes drug ORMD-0801 after a Phase 3 clinical trial missed its primary and s...
Federal Register notice: FDA releases a draft guidance entitled Photobiomodulation (PBM) Devices Premarket Notification [510(k)] Submissions.
FDA signs a good pharmaceutical manufacturing practice mutual recognition agreement with Switzerland and its regulatory agencies.
CDRHs Suzanne Schwartz says FDA is glad it now has the legal authority to require medical device manufacturers to address cybersecurity issues in thei...
Researchers call on the National Committee on Vital and Health Statistics to approve a proposal to add medical device unique identifiers to health sys...
FDA issues Biocon Biologics a complete response letter on its BLA for a biosimilar version of insulin aspart, citing additional data being needed and ...
Physician advocacy group Doctors for America urges FDA to commit to convening an advisory committee meeting when it is time to consider the full appro...
FDA warns two Olympus endoscope and reprocessor manufacturing facilities about Quality System and Medical Device Reporting regulation violations.
