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FDA Safety Alert for Pediatric Revatio Use

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A new FDA drug safety alert recommends against prescribing Pfizers Revatio (sildenafil) for children with pulmonary arterial hyper...

FDA Approves Prostate Cancer Drug in 3 Months

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FDA approves in three months an Astellas Pharma NDA for Xtandi (enzalutamide) for treating men with late-stage (metastatic) castra...

Janssen Settlement Posted on Webview

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FDA Webview posts the court-approved 8/30 Janssen Pharmaceuticals settlement where the company agreed to pay $181 million to 37 st...

Janssen Files Submissions for Tuberculosis Antibiotic

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Janssen Cilag says it has filed an NDA and an European submission for bedaquiline for use in combination therapy with a background...

Boehringer Ingelheim/Pfizer to Present Spiriva Data

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Boehringer Ingelheim and Pfizer plan three data presentations testing COPD patients treated with Spiriva at the 2012 European Resp...

I-Flow Recalls Malfunctioning Pain Pump

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FDA says I-Flow Corp. has recalled its ON-Q pump with OnDemand bolus button because of a malfunction that could allow the pump to ...

GOP Pledges FDA Reforms

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The Republican platform pledges unspecified FDA reforms directed at keeping innovation and jobs in this country.

Janssen Paying $181 Million for Deceptive Ads

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Janssen agrees to pay $181 million to resolve deceptive advertising charges for its Risperdal and Invega filed by 37 states and Wa...

B. Braun Wants Hospira Lactated Ringers as RLD

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B. Braun asks FDA to designate Hospiras lactated ringers as the reference-listed drug.

Workshop on Device Postmarket Surveillance

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Federal Register Notice: FDA will hold a public meeting 9/10, Public Meeting Strengthening the National Medical Device Postmarket...