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CDRH Approves Bayer Essure Study Plan

[ Price : $8.95]

CDRH approves an updated postmarket study plan submitted by Bayer to assess safety and efficacy issues involving its controversial...

Celator Investigational Drug Misbranded: OPDP

[ Price : $8.95]

CDERs Office of Prescription Drug Promotion cautions Celator that a convention panel misbrands its investigation cancer drug CPX-3...

Sage Given Breakthrough Status for Postpartum Depression Drug

[ Price : $8.95]

FDA grants Sage Therapeutics a breakthrough therapy designation for SAGE-547 for treating postpartum depression.

Ariad NDA Filed for Brigatinib in Lung Cancer Patients

[ Price : $8.95]

Ariad Pharmaceuticals completes a rolling NDA submission for its investigational anaplastic lymphoma kinase (ALK) inhibitor, briga...

FDA Orphan Status for Catalyst Firdapse in New Indication

[ Price : $8.95]

FDA grants Catalyst Pharmaceuticals an orphan drug designation for Firdapse (amifampridine phosphate) for treating myasthenia grav...

Hill Letter Questions Mylan EpiPen Medicaid Rebate Classification

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U.S. lawmakers question Mylans classification and rebate obligations under the Medicaid Drug Rebate Program for its controversial ...

CDRH Allows Marketing of Clot Removal Device

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CDRH allows under its de novo review the marketing of Concentric Medicals two Trevo clot retrieval devices as an initial therapy f...

FDA Bans 19 Ingredients in OTC Antiseptic Wash Products

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FDA issues a final rule that bans 19 active ingredients including most commonly triclosan and triclocarban from use in over-the-...

Fast Track Granted for Biogen Alzheimers Drug

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FDA grants Biogen fast track status for aducanumab, an investigational treatment for early Alzheimers disease.

Baxter Tells FDA of Vascu-Guard Issues

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FDA warns healthcare providers about risks associated with using the Baxter Vascu-Guard patch in carotid endarterectomy procedures...