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Biologics

Evolus Resubmits BLA for Botox Competitor

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

Human Drugs

Advisors to Review Fentanyl REMS

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

Human Drugs

Mixed-Bag Decision for Novartis

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

Human Drugs

Cutting-edge Manufacturing Research Grants Awarded

FDA awards three cutting-edge manufacturing technology research grants.

Federal Register

Prescription Drug User Fee Rates for FY 2019

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

Federal Register

FY 2019 Drug Compounding Rates

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

Human Drugs

AuroMedics Recalls 2 Lots of Piperacillin and Tazobactam

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

Human Drugs

FDA OKs Shionogi NDA for Mulpleta for Thrombocytopenia

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

Medical Devices

Modulated Imagings Clarifi Device Cleared

Modulated Imaging has received FDA clearance for its Clarifi Imaging System, a diagnostic device that uses spatial frequency domain imaging to help cl...

Human Drugs

CGMP Violations at BioDiagnostic International

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