Polpharma Biologics Announces FDA and EMA Acceptance for Review of PB016 Vedolizumab Biosimilar Candidate
The BLA and MAA acceptances represent significant milestones in Polpharma [...]
Fresenius Announces FDA and EMA Acceptance for Review of Vedolizumab Biosimilar Candidate
Acceptance reinforces Fresenius Kabi’s strategy to expand its autoimmune biosimilars [...]
Aidoc Receives FDA Breakthrough Device Designation for AI That Drafts Radiology Reports
First Read is designed to help radiologists meet rising imaging [...]
Cercare Medical Receives FDA 510(k) Clearance for Cone-Beam CT Perfusion
The clearance marks an important step forward in acute stroke [...]
TaeWoong Medical USA Receives FDA 510(k) Clearance for SPAXUS™, Expanding Its EUS Therapeutic Portfolio
The FDA determined the SPAXUS Stent to be substantially equivalent [...]
Grifols Gets FDA Approval for Malaria Blood Screening Assay
The Procleix Plasmodium Assay aims to improve blood safety by [...]
Cala Wins FDA Clearance for New TAPS Wearable for Tremor and Parkinson’s
The Cala kIQ Plus provides new therapy modes and adaptive [...]
SwiftMR® by AIRS Medical Gains FDA Clearance for Use with OEM Deep Learning MRI Solutions
SwiftMR®, is an FDA 510(k)-cleared, vendor-neutral MRI image enhancement solution [...]
Restore Robotics Receives FDA 510(k) Clearance for 2 Additional da Vinci Xi® Robotic Instruments
With these latest clearances, Restore Robotics continues to deliver on [...]
Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (setmelanotide) for Patients with Acquired Hypothalamic Obesity
First and only FDA-approved therapy for the treatment of acquired [...]