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FDA converts approval process for new Alzheimer’s disease treatment to traditional approval

The US Food and Drug Administration (FDA) converted the approval process for Leqembi ( lecanemab-irmb), indicated for the treatment of adult patients with Alzheimer's...

Amneal Launches Authorized Generic for Xyrem® (sodium oxybate) and Receives FDA Approval for Five Complex Generics in the Second Quarter

Amneal Pharmaceuticals, Inc. announced the launch of its authorized generic for Xyrem® (Sodium Oxybate) oral solution CIII in the United States. Sodium Oxybate oral solution,...

SimonMed Imaging Implements 3rd Generation iCAD Breast AI 3.0

SimonMed Imaging, one of the largest outpatient imaging providers in the US, announced it has completed the implementation of its third generation breast artificial...

ZEISS Accelerates Validation Process for Coordinate Measuring Machines to Achieve FDA Compliance

ZEISS is now offering customers validation solutions for their ZEISS Coordinate Measuring Machines (CMMs). The validation of quality assurance systems is essential for complying...

FDA GRANTS FULL APPROVAL FOR BLINCYTO® (BLINATUMOMAB) TO TREAT MINIMAL RESIDUAL DISEASE-POSITIVE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA

Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) for the treatment of...
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