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Pfizer Expands Chantix Recall

[ Price : $8.95]

FDA says Pfizer is expanding its Chantix recall and Apotex can temporarily distribute some of its generic Chantix product in the U...

Stakeholders Urged to Transform Drug Supply Chain

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A Business Group on Health study group recommends changes to the pharmaceutical supply chain system to counter government drug pri...

First Lights C. Difficile Test Cleared

[ Price : $8.95]

FDA clears a First Light Diagnostics 510(k) for its SensiTox C. difficile toxin test along with its proprietary MultiPath Analyzer...

Statin Pregnancy Contraindication Lifted

[ Price : $8.95]

FDA announces a class-wide labeling change for cholesterol-lowering statin drugs to remove its strongest warning against their use...

FDA Denies Professors Tolvaptan Petition

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FDA denies a petition asking it to withdraw approval of Osakas Jynarque for treating autosomal dominant polycystic kidney disease....

NeuroMetrix Breakthough on Fibromyalgia Device

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FDA grants NeuroMetrix a breakthrough designation for its Quell device and its use in treating the symptoms of fibromyalgia in adu...

Ortho Regenerative Submits Response to Ortho-R Clinical Hold

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Ortho Regenerative Technologies says it has submitted information requested by FDA to resolve a clinical hold on the Ortho-R drug/...

Domestic Inspections Resume Standard Operations

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FDA acting commissioner Janet Woodcock says that beginning this month, FDA started transitioning back to standard operations for d...

FDA Approves Mercks Pneumococcal Vaccine

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FDA approves Mercks Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for active immunization for preventing invasive disease...

FDA Accepts Aquestive NDA Resubmission

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FDA accepts for review an Aquestive Therapeutics NDA resubmission for Libervant (diazepam) Buccal Film for managing seizure cluste...