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XBiotech Sees Positive Trend in Phase 3 Xilonix Trial

[ Price : $8.95]

XBiotech says an unscheduled interim analysis of data from a Phase 3 trial of Xilonix shows a trend for improved survival in advan...

FDA Clears Otoharmonics 510(k) for Tinnitus

[ Price : $8.95]

FDA grants 510(k) clearance for Otoharmonics Levo System for use in temporarily relieving the symptoms of tinnitus.

Surge in NME Approvals Being Seen This Year

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CDER drug approval reports show the Center is on track to substantially exceed last years 27 new molecular entity (NME) drug produ...

GE SenoClaire 3-D Breast Tomosynthesis Solution Approved

[ Price : $8.95]

FDA approves GE Healthcares SenoClaire breast tomosynthesis solution designed with a three-dimensional imaging technology.

Advisors to Look at Testosterone Population, Risks

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FDA says members of its Bone, Reproductive, and Urologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Com...

Pew, Others Call for Changes to Medical Device Registries

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Three health organizations say that healthcare experts believe there are steps that could be taken to make registries more useful ...

Early Growth Response 1 Gene FISH System into Class 2

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Federal Register Final order: FDA classifies early growth response 1 gene fluorescence in-situ hybridization test system for speci...

More Clinical Trial Data Transparency Needed from FDA: Panel

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A House Energy and Commerce Committee roundtable discusses how FDA, industry and Congress should work together to craft legislatio...

Carousel Solutions Inspection Finds QS Problems

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FDAs Seattle District Office warns Carousel Solutions about Quality System Regulation violations in its work as a medical device s...

QS Problems Found at Iradimed

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FDAs Florida District Office warns Iradimed about Quality System and other violations in its manufacturing of MRI infusion pumps a...