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Subcutaneous Benlysta Approved for Pediatric Lupus

[ Price : $8.95]

FDA approves a 200 mg subcutaneous route of administration of GSKs Benlysta (belimumab) for patients five years of age and older w...

CGMP Violations Found in Seatex Inspection

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FDA warns Rosenberg, TX-based Seatex about CGMP violations in its manufacturing of finished drugs.

Zika No Longer Relevant Disease: FDA

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FDA says it no longer is requiring HCT/P donor screening for the Zika virus because the virus no longer has sufficient incidence o...

MDMA Suggests Changes to Cybersecurity Guidance

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The Medical Device Manufacturers Association requests changes to several aspects of an FDA draft guidance on premarket cybersecuri...

Subcutaneous Opdivo User Fee Date Shortened

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FDA revises its user fee review action date from 2/28/2025 to 12/29/2024 for a Bristol Myers Squibb BLA for a subcutaneous formula...

AdvaMed Seeks More Efficient Feedback Requests

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The Advanced Medical Technology Association says FDAs new draft guidance on Requests for Feedback and Meetings for Medical Device ...

Ultrasound Devices for Glaucoma Reclassified

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Federal Register notice: FDA issues a final order reclassifying the ultrasound cyclodestructive device, a postamendments Class 3 d...

CVM Policy on Foods with Drug Claims Withdrawn

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Federal Register notice: FDA announces the withdrawal of the Center for Veterinary Medicines Program Policy and Procedures Manual ...

2 Interchangeable Eylea Biosimilars Approved

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FDA approves two BLAs for interchangeable biosimilars to Regenerons Eylea (aflibercept) Biocon Biologics Yesafili (aflibercept-jb...

Meditrina 2nd Gen Hysteroscopy System Cleared

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FDA clears a Meditrina 510(k) for its second generation bipolar radiofrequency Aveta Glo hysteroscopy system.