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Accelerated Approval for AstraZeneca Lung Cancer Drug

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FDA grants accelerated approval for an AstraZeneca NDA for Tagrisso (osimertinib), an oral medication to treat patients with advan...

Petition Seeks Removal of Phenylephrine from Monograph

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A citizen petition urges FDA to issue a final rule removing oral phenylephrine from the Final Monograph for Over-the-counter Nasal...

FDA Orders Recall of Endoscope Cleaners Under Decree

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FDA orders Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) due to its continued violations of a 20...

White-Hat Hacker Demonstrates Device Vulnerability

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Bloomberg Business reports on a corporate hackers experience demonstrating cyber vulnerabilities in a Hospira infusion pump.

Amgen Humira Biosimilar Sees Positive Trial Results

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Amgen says a head-to-head Phase 3 study comparing its biosimilar candidate ABP 501 to AbbVies rheumatoid arthritis drug Humira (ad...

Collaborating on Next-generation Sequencing

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Three FDA staffers say that the agency wants to collaborate with external stakeholders on steps to ensure that next-generation seq...

FDA Urging Medical Device Quality

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Three top FDA executives describe the Case for Quality initiative and its three goals for overcoming barriers to improving medical...

New Drug Trial Disclosures Below Legal Standards

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Researchers say that too many drug clinical trials still are not being reported publicly.

FDA Clears Perspectum Diagnostics LiverMultiScan

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FDA clears a Perspectum Diagnostics 510(k) for the LiverMultiScan imaging device, which is intended to detect early liver disease ...

Califf Led a Biased Xarelto Clinical Trial: POGO

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Project On Government Oversight charges that FDA commissioner-nominee Robert Califf led a clinical trial that was sharply criticiz...