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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
Amarantus seeks US FDA orphan drug status for MANF to treat retinitis pigmentosa

Amarantus Bioscience Holdings, a biotechnology company focussed on the development of diagnostics and therapeutics for Alzheimer's disease,... ...

http://www.pharmabiz.com/NewsDetails.aspx?aid=84665&sid=2
Basilea reports protocol amendment resulting in earlier completion of isavuconazole phase 3 invasive candidiasis study

Custom Search Basilea reports protocol amendment resulting in earlier completion of isavuconazole phase 3 invasive candidiasis study... ...

http://www.bizwireexpress.com/showstoryGNW.php?storyid=46226
U.S. FDA Accepts Eisai's sNDA for BANZEL (Rufinamide) as Adjunctive Treatment in Pediatric Patients With Lennox-Gastaut Syndrome

Eisai (JCN Newswire) 2014-10-15 Tokyo, Oct 15, 2014 - ( JCN Newswire ) - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai")... ...

http://www.bizwireexpress.com/showstoryJCN.php?storyid=266610
Rockwell Medical Announces FDA Advisory Committee Review of Triferic for the Treatment of Iron Replacement and Maintenance of Hemoglobin in Hemodialysis Patients

WIXOM, Mich., Oct. 9, 2014 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (Nasdaq:RMTI), a fully integrated biopharmaceutical company targeting... ...

http://www.bizwireexpress.com/showstoryGNW.php?storyid=45483
RAPIVAB(TM) Trial Results for the Treatment of Influenza to be Presented at IDWeek 2014

Custom Search RAPIVAB(TM) Trial Results for the Treatment of Influenza to be Presented at IDWeek 2014 GlobeNewswire 2014-10-08 RESEARCH... ...

http://www.bizwireexpress.com/showstoryGNW.php?storyid=45318

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