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FDA Panel to Review Resubmitted Testosterone NDA

[ Price : $8.95]

FDA tells Lipocine that the agencys Bone, Reproductive and Urologic Drugs Advisory Committee plans to discuss the companys NDA for...

FDA Clears Stryker 3D Printed Cervical Cage

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FDA clears a Stryker Spine division 510(k) for its Tritanium C Anterior Cervical Cage, a 3D-printed interbody fusion cage intended...

Pfizer Says J&J Illegally Blocking Remicade Competition

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Pfizer sues Johnson & Johnson claiming antitrust violations in J&J efforts to prevent purchasers and insurers from using Pfizers I...

FDA Warns of Medication-Assisted Treatment Drug Risks

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FDA cautions healthcare providers not to withhold two opioid addiction drugs from patients also taking central nervous system depr...

FDA Warns 13 Web Firms re Unlawful Drug Sales

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FDA tells 13 Internet companies to stop selling unapproved new drugs and misbranded drugs in the U.S.

FDA Clears Revamped Pentax Duodenoscope

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FDA clears a Pentax of America 510(k) for the first duodenoscope with a disposable distal cap, a new feature that is intended to i...

Medical Device Inspection Changes in Reauthorization

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Attorneys review medical device inspection changes included in the FDA Reauthorization Act of 2017.

CGMP Violations at Koreas Firson Company

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FDA warns Koreas Firson Company about CGMP violations in the production of finished pharmaceuticals.

FDA OKs Glaxo/Innoviva Triple Therapy for COPD

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FDA approves a GlaxoSmithKline and Innoviva NDA for a once-daily, single inhaler triple therapy Trelegy Ellipta (fluticasone furoa...

FDA Clears Arkis Bio Ventricular Drainage Catheter

[ Price : $8.95]

FDA clears an Arkis BioSciences 510(k) for its new CerebroFlo external ventricular drainage catheter.