New Drug Application News and Research

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WuXi PharmaTech subsidiary enters into supply arrangement with Pharmacyclics

WuXi PharmaTech subsidiary enters into supply arrangement with Pharmacyclics

15 Nov 2013
FDA Advisory Committee votes in favor of Vanda's tasimelteon NDA for Non-24-Hour Disorder

FDA Advisory Committee votes in favor of Vanda's tasimelteon NDA for Non-24-Hour Disorder

15 Nov 2013
Derma Sciences third quarter 2013 net sales increase 12% to $22.1 million

Derma Sciences third quarter 2013 net sales increase 12% to $22.1 million

13 Nov 2013
Orexigen Therapeutics reports net loss of $18.6 million in Q3 2013

Orexigen Therapeutics reports net loss of $18.6 million in Q3 2013

12 Nov 2013
European Medicines Agency awards orphan drug designation to NanoViricides' DengueCide

European Medicines Agency awards orphan drug designation to NanoViricides' DengueCide

11 Nov 2013
Mylan Pharmaceuticals launches Rabeprazole Sodium Delayed-release Tablets

Mylan Pharmaceuticals launches Rabeprazole Sodium Delayed-release Tablets

11 Nov 2013
GW Pharmaceuticals starts Phase 1b/2a clinical trial for Recurrent Glioblastoma Multiforme

GW Pharmaceuticals starts Phase 1b/2a clinical trial for Recurrent Glioblastoma Multiforme

11 Nov 2013
PDL BioPharma closes financing transaction with Durata Therapeutics

PDL BioPharma closes financing transaction with Durata Therapeutics

6 Nov 2013
Aeterna Zentaris submits macimorelin acetate NDA to FDA

Aeterna Zentaris submits macimorelin acetate NDA to FDA

5 Nov 2013
Reviva announces successful completion of End-of-Phase 2 meeting for RP5063 drug

Reviva announces successful completion of End-of-Phase 2 meeting for RP5063 drug

5 Nov 2013
Actavis seeks FDA approval to market Isotretinoin Capsules

Actavis seeks FDA approval to market Isotretinoin Capsules

31 Oct 2013
Janssen submits Marketing Authorization Application for Ibrutinib

Janssen submits Marketing Authorization Application for Ibrutinib

30 Oct 2013
FDA issues final approval for Lupin's sNDA for Antara capsules

FDA issues final approval for Lupin's sNDA for Antara capsules

23 Oct 2013
Pfizer to continue development of Remoxy Extended-Release Capsules CII

Pfizer to continue development of Remoxy Extended-Release Capsules CII

22 Oct 2013
FDA approves Cubist Pharmaceuticals' sNDA for ENTEREG

FDA approves Cubist Pharmaceuticals' sNDA for ENTEREG

21 Oct 2013
Alimera Sciences receives Complete Response Letter for New Drug Application from FDA

Alimera Sciences receives Complete Response Letter for New Drug Application from FDA

19 Oct 2013
Medivir announces data from phase III studies of simeprevir in patients co-infected with HCV genotype-1 and HIV-1

Medivir announces data from phase III studies of simeprevir in patients co-infected with HCV genotype-1 and HIV-1

19 Oct 2013
pSivida reports that Alimera Sciences gets FDA Complete Response Letter for ILUVIEN NDA

pSivida reports that Alimera Sciences gets FDA Complete Response Letter for ILUVIEN NDA

18 Oct 2013
Results of Phase 3 clinical trial of contraceptive vaginal ring presented by Population Council

Results of Phase 3 clinical trial of contraceptive vaginal ring presented by Population Council

16 Oct 2013
Phase 3 study of idelalisibin reports positive results in CLL patients

Phase 3 study of idelalisibin reports positive results in CLL patients

10 Oct 2013

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