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FDA DrugSorb-ATR Options

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FDA suggests ways CytoSorbents can proceed with its de novo application for DrugSorb-ATR.

Act Against Compounded Semaglutide: Petition

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Wiley Rein petitions FDA to take seven specific actions to address public health risks associated with compounded semaglutide drug...

2 Eylea HD Submissions Get Review Extensions

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FDA extends until the fourth quarter the review of two Regeneron Pharmaceuticals regulatory submissions for Eylea HD (aflibercept)...

B. Braun Recalls 2 Drugs Over Particulate Matter

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B. Braun Medical recalls (Class 1) one lot each of its Lactated Ringers Injection USP 1,000 mL and 0.9% sodium chloride injection...

Multiple Les Encres Violations

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FDA warns Lenoir City, TN-based Les Encres LLC about QS and MDR violations in its illegal work as a specification developer for ad...

Alcohol Use Disorder Drug Gets Fast Track

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FDA grants Altimmune a fast track designation for pemvidutide and its use for treating alcohol use disorder.

CGMP Violations Seen in Anhui Hanbon Inspection

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FDA warns Chinas Anhui Hanbon Daily Chemical Co. about CGMP violations in its production of finished drugs.

FDA Pushes Back Review of Hunter Syndrome BLA

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FDA extends by 90 days its review of a Regenxbios BLA for RGX-121 (clemidsogene lanparvovec), an investigational gene therapy for ...

PTC Therapeutics Friedreichs Ataxia Drug Rejected

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FDA rejects a PTC Therapeutics NDA for vatiquinone and its use for treating Friedreichs ataxia, saying additional evidence of the ...

Clinical Hold on BiomX Cystic Fibrosis Therapy

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FDA places a clinical hold on a BiomX Phase 2b trial of BX004, an investigational phage therapy for cystic fibrosis.