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Accelerated Approval to Prevent Sucraid Shortage

[ Price : $8.95]

FDA accelerates approval of manufacturing changes to QOL Medicals Sucraid to prevent drug shortages.

Nubain Not Withdrawn for S&E

[ Price : $8.95]

Federal Register Notice: FDA determines that Nubain injection, 10 and 20 mg/ml was not withdrawn from sale for reasons of safety a...

Panel to Discuss Erbitux and Vectibix Oncology Drugs

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Federal Register Notice: FDAs Oncologic Drugs Advisory Committee will meet 12/16.

Advisors Nix Arpidas Iclaprim

[ Price : $8.95]

FDAs Anti-infective Drugs Advisory Committee votes not to recommend approval of Arpidas intravenous antibiotic iclaprim.

FDA Accepts Vanda Resubmission for Schizophrenia NDA

[ Price : $8.95]

FDA accepts for review a Vanda Pharmaceuticals NDA resubmission for iloperiodone that is its complete response to a 7/25 not appro...

FDA Clears Bovie Medical Tissue Resection Device

[ Price : $8.95]

FDA clears a Bovie Medical Corp. 510(k) for the Seer tissue resection device intended for initial use in liver oncology surgery.

Leucovorin, Levoleucovorin Shortage Info Updated

[ Price : $8.95]

FDA updates shortage information for Teva and Bedfords leucovorin products and Spectrums levoleucovorin.

Advisors Doubt Oritavancin Safety, Effectiveness

[ Price : $8.95]

FDAs Anti-infective Drugs Advisory Committee says, by a narrow vote, that Targantas oritavancin is not safe or effective for treat...

Animas Class 1 Pump Battery Cap Recall

[ Price : $8.95]

FDA says Animas recall of defective insulin pump battery caps is a Class 1 recall.

FDA OKs Arcutis Pharma Acne Gel

[ Price : $8.95]

FDA approves an Arcutis Pharmaceuticals NDA for Acanya Gel, indicated for once-daily treatment of acne vulgaris.