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New rules for Indian generic drug makers

All generic drug makers, including Ranbaxy Laboratories, Cipla, Dr Reddy's Laboratories and Lupin, are now required to pay a fee to the US drug regulator while seeking permission to launch their......
  Web results for Pdufa
Advanced Accelerator Applications Announces FDA Priority Review for Lutathera

GlobeNewswire 2016-06-27 SAINT-GENIS-POUILLY, France, June 27, 2016 (GLOBE NEWSWIRE) -- Advanced Accelerator Applications S.A. (NASDAQ:AAAP)... ...

http://www.bizwireexpress.com/showstoryGNW.php?storyid=124872
TESARO Announces Rolapitant Data Presentations at the 2016 MASCC/ISOO Annual Meeting on Supportive Care in Cancer

GlobeNewswire 2016-06-23 ADELAIDE, Australia, June 23, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused... ...

http://www.bizwireexpress.com/showstoryGNW.php?storyid=124725
FDA Completes Pre-Approval Inspection of Emergent BioSolutions Large-Scale Manufacturing Facility for BioThrax

GlobeNewswire 2016-06-21 GAITHERSBURG, Md., June 21, 2016 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that the... ...

http://www.bizwireexpress.com/showstoryGNW.php?storyid=124249
U.S. FDA grants Priority Review for Nicox's AC-170 New Drug Application

GlobeNewswire 2016-06-21 FDA assigns Prescription Drug User Fee Act (PDUFA) goal date of October 18, 2016 SOPHIA ANTIPOLIS, France, June 21,... ...

http://www.bizwireexpress.com/showstoryGNW.php?storyid=124214
Charleston, Daiichi Sankyo announce US FDA accepts NDA for CL-108

Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. announced that the US Food and Drug Administration (FDA) has accepted for review the New... ...

http://www.pharmabiz.com/NewsDetails.aspx?aid=95716&sid=2

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