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Hacked Clinton Email Implicates FDA in Irregularities

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A Hillary Clinton presidential campaign hacked email released by Wikileaks shows how former president Bill Clinton and other top D...

FDA Approves Genentechs Tecentriq for Lung Cancer

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FDA approves Genentechs Tecentriq (atezolizumab) for treating people with metastatic non-small cell lung cancer.

Comments Sought on PMA Information Collection Requirements

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Federal Register Notice: FDA seeks comments on extending a collection of information on requirements for medical device PMA submis...

FDA Determines Regulatory Review Period for Repatha

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Federal Register Notice: FDA determines the regulatory review period for Amgens Repatha (evolocumab) for patent extension purposes...

CBER Changes Organizational Structure

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CBER changes its organizational structure to become more efficient at its regulatory duties.

AstraZeneca Resubmits NDA for Hyperkalemia Drug

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FDA accepts an AstraZeneca NDA re-submission for sodium zirconium cyclosilicate (ZS-9), indicated for treating hyperkalemia (high ...

FDA Clinical Hold on Reneneron/Teva Back Pain Drug

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FDA places a clinical hold on a Regeneron Pharmaceuticals and Teva Pharmaceutical Industries Phase 2b clinical trial of fasinumab ...

CDER Denies PTC Therapeutics Appeal on Duchenne Drug

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CDERs Office of Drug Evaluation 1 denies a PTC Therapeutics appeal of a 2/22 refuse-to-file letter issued by the Division of Neuro...

Purdue Wants Restrictions on Butrans Follow-ons

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Purdue Pharma asks FDA not to approve any ANDAs or new drug applications referencing its Butrans transdermal system unless the fol...

Gilead Seeks NCE Exclusivity for Stribild

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Gilead asks FDA to reconsider its decision not to grant NCE exclusivity to its Stribild in light of a recent DC federal court deci...