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Sponsored Links Misbrand Eton Alkindi Sprinkle: OPDP

[ Price : $8.95]

The CDER Office of Prescription Drug Promotion cautions Eton that online sponsored links for its Alkindi Sprinkle dont contain any...

FDA Says Pfizer Expands Chantix Recall Again

[ Price : $8.95]

FDA says Pfizer has recalled four additional lots of Chantix due to the presence of an unacceptable level of N-nitroso-varenicline...

FDA Fast Track Designation for Senhwas Silmitasertib

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FDA grants fast track designation to Senhwa Biosciences silmitasertib for treating recurrent sonic hedgehog medulloblastoma.

FDA Clears Qure.ai qER-Quant for Brain CT Scans

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FDA clears a Qure.ai brain imaging quantification product.

Drug, Device Recalls Continue to Go Down: Sedgwick

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The Sedgwick recall index says both medical device and pharmaceutical recalls continued to drop in the second quarter of 2021, hit...

FDA Clears Zimmer Biomet Rosa Hip

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FDA clears a Zimmer Biomet 510(k) for its Rosa Hip System for robotically-assisted direct anterior total hip replacement.

CardioNXT Heart Treatment Navigation System Cleared

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FDA clears a CardioNXT 510(k) for its heart treatment delivery platform.

Petition Wants NAC Declared Legal Dietary Ingredient

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The Natural Products Association asks FDA to declare N-acetyl-L-cysteine a legal dietary supplement ingredient.

AdvaMed Comments on CDRH Discussion Paper

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AdvaMed provides comments in three categories on a CDRH discussion paper on a framework for conveying materials information to pat...

GSK Accelerated Approval for Tumor Drug Jemperli

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FDA grants GlaxoSmithKline an accelerated approval for Jemperli (dostarlimab-gxly) for adult patients with mismatch repair deficie...