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FDA Clears Vapotherm Heliox Device

[ Price : $8.95]

FDA clears a Vapotherm 510(k) for the Precision Flow Heliox, a high-flow humidification system designed for use with blended heliu...

Final Birth Control Blood Clot Report Backs Concerns

[ Price : $8.95]

FDA says that results of a study it funded confirm an association between some birth control pills and increased risk of blood clo...

FDA OKs Mylan's Generic MS Contin

[ Price : $8.95]

FDA approves a Mylan Pharmaceuticals ANDA for a generic version of Purdue Pharma's MS Contin.

FDA OKs Lantheus Ultrasound Contrast Agent Labeling Changes

[ Price : $8.95]

FDA approves Lantheus Medical Imagings proposed labeling changes removing statements from the warning sections of the labeling for...

FDA Delays Dapagliflozin PDUFA Action Date

[ Price : $8.95]

FDA delays for three months its PDUFA action date for Bristol-Myers Squibb/AstraZenecas dapagliflozin NDA for treating Type 2 diab...

Harmonization Needs Industrys Collective Persuasion: FDAer

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A senior FDA official opines that it will probably take collective persuasion from industry to bring international harmonization t...

Public Citizen Wants Tygacil Boxed Warning

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Public Citizen calls on FDA to add a Boxed Warning of increased mortality risk to the labeling for Tygacil.

FDA Grants $2 Million for Regulatory Science Centers

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FDA awards $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation.

Pay-for-delay Continues to Grow: FTC

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The Federal Trade Commission says there were almost as many potential pay-for-delay patent settlements in the last two fiscal year...

Stevens Case Dismissal Helps In-house Counsel: Attorneys

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Lane Powell attorneys say the dismissal of felony obstruction charges against former GSK associate general counsel Lauren Stevens ...