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Korea-based Hugel resubmits its BLA for its botulinum toxin Letybo (letibotulinumtoxinA), indicated for treating glabellar (frown)...[ Price : $8.95]
Sage Therapeutics says it is downsizing and reorganizing to prepare for the launch of its postpartum depression drug Zurzuave late...[ Price : $8.95]
Becton Dickinson asks the FDA Microbiology Devices Panel to consider four points at its 9/8 discussion of diagnostic devices in fu...[ Price : $8.95]
Datascope begins an FDA-rated Class 1 recall of its Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) due t...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Enhanced Drug Distribution Security at the Package Level Un...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Considerations for the Use of Real-World Data and Real-Worl...[ Price : $8.95]
AdvaMed lists steps the federal government could take to improve patient access to at-home medical technologies.[ Price : $8.95]
FDA clears an Alcresta Therapeutics 510(k) for an expanded use for ReliZorb in children ages two to five years.