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Evolus Resubmits BLA for Botox Competitor

[ Price : $8.95]

Evolus resubmits a BLA for DWP-450 (prabotulinumtoxinA) for treating glabellar lines, also known as frown lines, in adult patients...

Advisors to Review Fentanyl REMS

[ Price : $8.95]

FDA asks two advisory committees to discuss how effective the transmucosal immediate-release fentanyl REMS is and how it can be im...

Mixed-Bag Decision for Novartis

[ Price : $8.95]

Attorney Michelle Yeary finds things to appreciate and not agree with in a Florida federal court decision in a suit against Novart...

Cutting-edge Manufacturing Research Grants Awarded

[ Price : $8.95]

FDA awards three cutting-edge manufacturing technology research grants.

Prescription Drug User Fee Rates for FY 2019

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Federal Register notice: FDA announces the fiscal year 2019 for prescription drug user fees.

FY 2019 Drug Compounding Rates

[ Price : $8.95]

Federal Register notice: FDA announces the fiscal year 2019 rates for the establishment and re-inspection fees related to entities...

AuroMedics Recalls 2 Lots of Piperacillin and Tazobactam

[ Price : $8.95]

AuroMedics Pharma recalls two lots of piperacillin and tazobactam for injection, USP 3.375 g due to concerns that vials may contai...

FDA OKs Shionogi NDA for Mulpleta for Thrombocytopenia

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FDA approves a Shionogi NDA for Mulpleta (lusutrombopag), a once-daily, orally administered, small molecule thrombopoietin recepto...

Modulated Imagings Clarifi Device Cleared

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Modulated Imaging has received FDA clearance for its Clarifi Imaging System, a diagnostic device that uses spatial frequency domai...

CGMP Violations at BioDiagnostic International

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FDA warns BioDiagnostics International about CGMP and other violations in its manufacturing of finished pharmaceuticals.