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Amgen sNDA on Kyprolis Superiority Data Under FDA Review

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FDA accepts an Amgen supplemental NDA for Kyprolis (carfilzomib) and dexamethasone that includes overall survival data from the Ph...

FDA Clears Smiths Medical CADD-Solis Infusion Pump

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FDA clears a Smiths Medical 510(k) for the CADD-Solis ambulatory infusion pump with wireless communication.

CGMP Violations at Indias Hetero Labs

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FDA warns Indias Hetero Labs about CGMP violations in its manufacturing of finished pharmaceuticals.

FDA Refuses to File Inbrija NDA

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FDA says an Acorda Therapeutics NDA for Inbrija is not sufficiently complete to permit a substantive review.

FDA Approves Firmware Update for Some Abbott Pacemakers

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FDA approves a firmware update to Abbott (St. Jude) implantable pacemakers to correct a cybersecurity vulnerability that could lea...

Device User Fee Rates for FY 2018

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Federal Register notice: FDA announces medical device user fee rates and payment procedures for fiscal year 2018.

FDA Approves Boehringer Ingelheim Humira Biosimilar

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FDA approves a Boehringer Ingelheim Pharmaceuticals BLA for Cyltezo, a biosimilar version of Abbotts Humira (adalimumab) for multi...

Merck Mulls Anacetrapib NDA After Mixed Study

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Merck says its investigational drug anacetrapib reduced risk of major coronary events in patients with atherosclerotic vascular di...

BMS, Daiichi Sharing Breast Cancer Treatment Trial

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Bristol-Myers Squibb and Daiichi Sankyo say they are collaborating on a Phase 1b clinical trial of Opdivo and an investigational D...

Biomarker Context of Use Post

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FDA explains its biomarker qualification context of use statement.