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Sponsored Links Misbrand Eton Alkindi Sprinkle: OPDP

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

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...

Courts Strengthen Implied Preemption of Drug Changes

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Attorney Andrew Tauber says two appeals court decisions in the last three years have strengthened implied preemption of state law ...

FDA Pediatric ECG Warehouse Helps Product Development

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FDA says a new pediatric electrocardiogram data warehouse already has almost 40,000 reports to be used in assessing cardiac risk t...

FDA Approves Jardiance for Heart Failure

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FDA approves Boehringer Ingelheim and Eli Lillys diabetes drug Jardiance (empagliflozin) 10 mg for reducing the risk of cardiovasc...

FDA Warning on All Eco-Med Ultrasound Gels

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FDA issues a letter to healthcare providers warning them to stop using and discard all ultrasound gels and lotions manufactured by...

Abiomeds Impella Heart Pump Gets Breakthrough

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FDA grants a breakthrough designation to Abiomeds Impella ECP expandable percutaneous heart pump.

Slight Drop in Number of Drug Manufacturing Sites: Report

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The CDER State of Pharmaceutical Quality report for FY 2020 documents a slight decrease in the number of drug manufacturing sites ...

FDA Signals NDA Path for Virpax Nasal Anti-viral Barrier

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FDA tells Virpax Pharmaceuticals that it can proceed with additional research on MMS019, a high-density molecular masking spray un...

Intended Use Final Rule Analyzed

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Attorney Jeffrey Shapiro says the FDA final regulation on intended use is a modest improvement over past practice.