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FDA Clears Subcutaneous Leqembi Iqlik for At-Home Use
The FDA has approved Biogen and Eisai's Leqembi Iqlik, a subcutaneous version of their Alzheimer's treatment, for initiation and maintenance dosing, including...
#fda approval 4 articles
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Vertex’s Casgevy Approved for Children as Young as Two
Vertex Pharmaceuticals (VRTX) has received US FDA approval for its gene therapy Casgevy, expanding its indication to children as young as two...
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AbbVie’s Skyrizi Expands Pediatric Indication to Psoriatic Diseases
AbbVie's Skyrizi has received US FDA approval for children aged six and older with moderate-to-severe plaque psoriasis or active psoriatic arthritis. This...
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FDA Greenlights uniQure’s AMT-130 Data for Accelerated Approval Filing
uniQure's stock surged after the FDA indicated that three-year Phase I/II data for its Huntington's disease gene therapy, AMT-130, could support an...