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Workshop on Device Postmarket Surveillance Registries

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Federal Register Notice: FDA plans a public workshop 9/12-13: Leveraging Registries with Medical Device Data for Postmarket Survei...

Workshop on Mass Casualty Burn Injuries

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Federal Register Notice: FDA plans a public workshop 9/27-28, Medical Countermeasures (MCM) for a Burn Mass Casualty Incident.

FDA Giving Janssens Zytiga sNDA Priority Review

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FDA grants priority review for a new indication for Janssens Zytiga plus prednisone to treat some patients with metastatic castrat...

ArQule Reports Suspended Trial Using Lung Cancer Drug

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ArQule says enrollment in a trial to evaluate its investigational drug tivantinib for use in lung cancer patients has been tempora...

Sanofi Considered Social Media Leader

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Online postings credit Sanofi with taking the initiative to develop a social media presence for diabetes patients while other comp...

Noven NDA Filed for Menopause Symptoms

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Noven files an NDA that seeks approval to market low-dose mesylate salt of paroxetine for treating vasomotor symptoms associated w...

FDA Raises Kalydeco Cataract Concern

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FDA says the cystic fibrosis drug Kalydeco may cause cataracts in pediatric patients.

FDA Allowing Intermediate Risk Patients in CoreValve Trial

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FDA says Medtronic can add patients at intermediate risk for open-heart aortic valve replacement to its SURTAVI trial.

Simplifying Drug Protein Production

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A University of Arkansas chemical engineering researcher says she has developed a technique that will save drug companies time and...

Orphan Status for Narcolepsy Investigational Drug

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FDA grants Aerial BioPharma an orphan drug designation for ARL-N05 and its use in treating narcolepsy.