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Insight Pharma Recalls Nasal Decongestant

[ Price : $8.95]

Insight Pharmaceuticals recalls one lot of Nostrilla Nasal Decongestant nasal spray because it may contain Burkholderia cepacia.

FDA OKs Watsons Lower Dose Testosterone Patch

[ Price : $8.95]

FDA approves Watson Pharmaceuticals Androderm 2 mg and 4 mg testosterone patch indicated as testosterone replacement therapy in ma...

FDA OKs Ferring Euflexxa Osteoarthritis Labeling

[ Price : $8.95]

FDA approves a Ferring Pharmaceuticals labeling supplement for Euflexxa to include data from a 26-week safety and efficacy trial c...

Public Citizen Urges FDA to Not Approve Imaging Dye

[ Price : $8.95]

Public Citizen reiterates its call for FDA to not approve Avid Pharmaceuticals experimental imaging dye florbetapir for use in dia...

CDRH Taking New Innovation Steps

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CDRH announces additional steps it is taking in the pre-market process to promote medical device manufacturer success through inno...

Senators Want to Promote Antibiotic Development

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Senators Blumenthal and Corker introduce legislation to promote the development of new antibiotics to combat increasing resistance...

Dont Expand Xarelto Indication: Public Citizen

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Public Citizen says FDA should not approve an expanded indication for Bayers Xarelto in patients with atrial fibrillation.

Segasist Tech Prostate Imaging Software Cleared

[ Price : $8.95]

The agency clears a Segasist Technologies 510(k) for its Prostate Auto-Contouring software and its use in segmenting MRI, CT and u...

FDA Extends Tysabri sBLA Review

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FDA extends by three months its review of a Biogen Idec and Elan supplemental BLA for multiple sclerosis and Crohn's disease thera...

Baxter Warning Letter 'Closed-out'

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Baxter Healthcare says it has resolved GMP violations cited in a 1/20/11 Warning Letter involving its Jayuya and Guayama, Puerto R...