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FDA Approval

ADDF Statement on FDA Decision Not to Grant Accelerated Approval to Donanemab for Treatment of Alzheimer’s Disease

Drugmaker Eli Lilly & Co announced that the FDA has issued a complete response letter, meaning it has not granted accelerated approval for amyloid-clearing...

TG Therapeutics Announces FDA Approval of BRIUMVI

TG Therapeutics, Inc. announced the U.S. Food and Drug Administration (FDA) has approved BRIUMVI, for the treatment of relapsing forms of multiple sclerosis (RMS),...

Chocolate Touch, Next-Generation Drug-Coated Angioplasty Balloon for the Treatment

Genesis MedTech Group announced that the Food and Drug Administration (FDA) has approved the Chocolate Touch Drug-coated Balloon PTA Catheter, developed by TriReme Medical...

Nevro Announces FDA Approval of HFX iQ Spinal Cord Stimulation System

Nevro Corp., a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, announced that it has received...

StemCyte Announces FDA Approval of IND for a Phase II Clinical Trial

Southern California cord blood regenerative therapeutics company StemCyte is pleased to announce it has received approval from the U.S. Food and Drug Administration (FDA)...
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