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Xolair sBLA for Treating Nasal Polyps

[ Price : $8.95]

FDA accepts for review a Novartis supplemental BLA for Xolair (omalizumab) for treating nasal polyps in adult patients who do not ...

OTC Drug Reform Passes Senate

[ Price : $8.95]

The Senate votes 91-2 to approve legislation to reform the over-the-counter drug regulatory system.

Panel Rejects Correvios Vernakalant Over Safety

[ Price : $8.95]

FDAs Cardiovascular and Renal Drug Advisory Committee votes 11-2 against recommending approval of Correvio Pharmas vernakalant for...

Sozo Cleared for Assessing Protein Calorie Malnutrition

[ Price : $8.95]

FDA clears an ImpediMed 510(k) for Sozo, intended for use as an aid in assessing protein calorie malnutrition.

Courts Could See FDA Warning Letter as Final Action

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Attorney Michelle Yeary says a DC federal court decision might open the way for FDA Warning Letters to be considered final agency ...

CRN Praises Court Decision in Fish Oil Case

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The Council for Responsible Nutrition praises the Supreme Courts refusal to hear an Amrin appeal of a fish oil dietary supplement ...

Alert on Recalled Products from Basic Reset/Biogenyx

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FDA says 25 unapproved drug, dietary supplement and medical device product lines distributed by Basic Reset and Biogenyx, have bee...

Waxman-Hatch at Risk: Analysis

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Attorney Kurt Karst says Congress is considering drug pricing legislation that is opposed by the Association for Accessible Medici...

BIO Blasts USMCA Provision

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BIO president Jim Greenwood says the administration and House Democrats have surrendered a powerful tool to protect American biote...

Senators Want Action on Hearing Aid Regs

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Sens. Grassley and Warren ask FDA when draft OTC hearing aid regulations will be published