FDA Approves Genentech’s Gazyva® for Lupus Nephritis, Marking Breakthrough in Autoimmune Kidney Care
NEW YORK, Oct. 20, 2025 – The U.S. Food and Drug Administration (FDA) has approved Gazyva® (obinutuzumab), developed by...
FDAApproval
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Prytime Medical Gains First Extended FDA 510(k) Clearance for pREBOA-PRO™ Catheter
BOERNE, Texas, Oct. 8, 2025 – Prytime Medical Devices, Inc., a leader in endovascular hemorrhage control and resuscitation, announced...
AorticLab Secures FDA IDE Approval for FLOWer™ Clinical Pivotal Trial
TORINO, Italy – October 2, 2025 – AorticLab has achieved a major milestone with the U.S. Food and Drug...
Zoetis Secures Conditional FDA Approval for Dectomax®-CA1 in Cattle
Parsippany, NJ – September 30, 2025 – Zoetis Inc. announced that Dectomax®-CA1 Injectable has received conditional approval from the...
AbbVie Submits BLA for Pivekimab Sunirine to FDA for Rare Blood Cancer
North Chicago, IL – September 30, 2025 – AbbVie (NYSE: ABBV) announced the submission of a Biologics License Application...
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