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Amgen Seeking Expanded Uplizna Use

[ Price : $8.95]

Amgen says it will file a BLA supplement by 6/30 for Uplizna (inebilizumab-cdon) to expand its use to treat adults living with gen...

FDA Device Data Integrity Notifications

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Two Akin Gump attorneys discuss a new FDA Web page with information on medical device data integrity.

CGMP Deviation in Chemspec Chemicals Inspection

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FDA cautions Indias Chemspec Chemicals about a CGMP deviation in its production of active pharmaceutical ingredients.

7 Acne Products Recalled for Benzene: FDA

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FDA says manufacturers are recalling seven acne products containing benzoyl peroxide to the retail level after testing found possi...

Regulate NarxCare as Software as Medical Device: Petition

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The Doctor Patient Forum petitions FDA to regulate Bamboo Healths NarxCare platform and other prescription drug monitoring program...

DoJ Lawyer Tapped as FDA Chief Counsel

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HHS appoints Justice Department attorney Hilary Perkins to serve as FDA chief counsel.

J&Js Monarch Quest Bronchoscopy Navigation Cleared

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FDA clears a Johnson & Johnson MedTech 510(k) for its Monarch Quest, an advanced navigation technology for robotically assisted br...

Comments Reopened on Good Clinical Practice Guide

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Federal Register notice: FDA reopens the comment period for its draft guidance entitled E6(R3) Good Clinical Practice: Annex 2.

Priority Review for DMD Cardiomyopathy BLA

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FDA accepts for priority review an NS Pharma BLA for deramiocel, an investigational cell therapy for Duchenne muscular dystrophy c...

Zenrelia Promotions False and Misleading: FDA

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FDA warns Elanco Animal Health that promotional materials for its Zenrelia are misbranded due to false and misleading representati...