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Medtronic Drug-coated Balloon OK'd for In-stent Restinosis

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FDA approves a Medtronic PMA for the IN.PACT Admiral drug-coated balloon for treating in-stent restenosis in patients with periphe...

Advisors Want Chantix Boxed Warning Pulled

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A bare majority of members of two FDA advisory committees say the agency should remove a Boxed Warning on neuropsychiatric adverse...

Plasma Fibrinogen Biomarker Guidance

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FDA issues a guidance with a context of use for the biomarker plasma finrinogen in COPD clinical trials.

Bipartisan Drug Pricing Legislation

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Two senators and a representative introduce legislation to mandate reporting of some pending drug price increases to HHS.

FDA Approved Aralez NDA for Cardiovascular Drug

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FDA approves an Aralez Pharmaceuticals NDA resubmission for Yosprala (aspirin and omeprazole), indicated for the secondary prevent...

FDA Extends Review of Lexicon NDA for Carcinoid Syndrome

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FDA extends by three months its review of a Lexicon Pharmaceuticals NDA for telotristat etiprate, an oral drug for treating carcin...

Virtus Pharma Recalls 7 Lots of Hyoscyamine Sulfate

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Virtus Pharmaceuticals recalls seven batches of hyoscyamine sulfate (0.125mg) due to both superpotent and subpotent test results.

AATD Patients Want Better Treatment Options

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Alpha-1 Antitrypsin Deficiency patients tell FDA of their daily struggles and desires for improved treatment.

Varian Gains Clearance for Nexus DR Imaging System

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Varian Medical Systems receives 510(k) clearance to market the Nexus DR, a high resolution imaging system for X-ray imaging using ...

Guidance on Total Kidney Volume Biomarker

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FDA releases a guidance on Qualification of Biomarker Total Kidney Volume (TKV) in Studies for Treatment of Autosomal Dominant Pol...