Korea-based Hugel resubmits its BLA for its botulinum toxin Letybo (letibotulinumtoxinA), indicated for treating glabellar (frown) lines.
Sage Therapeutics says it is downsizing and reorganizing to prepare for the launch of its postpartum depression drug Zurzuave later this year.
Becton Dickinson asks the FDA Microbiology Devices Panel to consider four points at its 9/8 discussion of diagnostic devices in future pandemics.
Datascope begins an FDA-rated Class 1 recall of its Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) due to System Over-Temper...
Federal Register notice: FDA makes available a final guidance entitled Enhanced Drug Distribution Security at the Package Level Under the Drug Supply ...
Federal Register notice: FDA makes available a final guidance entitled Considerations for the Use of Real-World Data and Real-World Evidence to Suppor...
AdvaMed lists steps the federal government could take to improve patient access to at-home medical technologies.
FDA clears an Alcresta Therapeutics 510(k) for an expanded use for ReliZorb in children ages two to five years.
