New Drug Application News and Research

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Bristol-Myers Squibb first quarter net sales increase 5% to $3.3 billion

Bristol-Myers Squibb first quarter net sales increase 5% to $3.3 billion

30 Apr 2011
Centocor Ortho Biotech Products withdraws NDA for trabectedin for treatment of women with ROC

Centocor Ortho Biotech Products withdraws NDA for trabectedin for treatment of women with ROC

30 Apr 2011
NeurogesX first quarter revenue is $3.2 million for 2011

NeurogesX first quarter revenue is $3.2 million for 2011

30 Apr 2011
Antiviral Drugs Advisory Committee recommends FDA to approve telaprevir for hepatitis C

Antiviral Drugs Advisory Committee recommends FDA to approve telaprevir for hepatitis C

29 Apr 2011
Takeda, Affymax announce additional peginesatide Phase 3 study results in dialysis patients

Takeda, Affymax announce additional peginesatide Phase 3 study results in dialysis patients

29 Apr 2011
Curis reports first quarter net loss of $6.8 million

Curis reports first quarter net loss of $6.8 million

28 Apr 2011
Celgene non-GAAP total revenue increases 40% to $1.11 billion

Celgene non-GAAP total revenue increases 40% to $1.11 billion

28 Apr 2011
FDA Advisory Committee recommends approval of Merck's VICTRELIS for chronic HCV genotype 1 infection

FDA Advisory Committee recommends approval of Merck's VICTRELIS for chronic HCV genotype 1 infection

28 Apr 2011
Watson reports net revenue of $876.5 million for first quarter 2011

Watson reports net revenue of $876.5 million for first quarter 2011

27 Apr 2011
Columbia requests FDA Priority Review for PROCHIEVE progesterone gel NDA

Columbia requests FDA Priority Review for PROCHIEVE progesterone gel NDA

27 Apr 2011
FDA supports new Hepatitis C drug from Vertex Pharmaceuticals

FDA supports new Hepatitis C drug from Vertex Pharmaceuticals

26 Apr 2011
KemPharm to formulate and develop KP106 as oral film dosage for ADHD treatment

KemPharm to formulate and develop KP106 as oral film dosage for ADHD treatment

26 Apr 2011
A.P. Pharma targets resubmission of APF530 NDA in 2012

A.P. Pharma targets resubmission of APF530 NDA in 2012

25 Apr 2011
Curemark CM-182 demonstrates positive results for schizophrenia in transgenic chakragati model of psychosis

Curemark CM-182 demonstrates positive results for schizophrenia in transgenic chakragati model of psychosis

25 Apr 2011
MonoSol Rx, KemPharm enter development and commercialization partnership for ADHD prodrug

MonoSol Rx, KemPharm enter development and commercialization partnership for ADHD prodrug

25 Apr 2011
POZEN, AstraZeneca file lawsuit against Dr. Reddy's for patent infringement relating to VIMOVO

POZEN, AstraZeneca file lawsuit against Dr. Reddy's for patent infringement relating to VIMOVO

25 Apr 2011
XenoPort files SPA with FDA for arbaclofen placarbil Phase 3 trial in multiple sclerosis

XenoPort files SPA with FDA for arbaclofen placarbil Phase 3 trial in multiple sclerosis

25 Apr 2011
Eisai receives FDA Complete Response Letter for Aricept Patch NDA

Eisai receives FDA Complete Response Letter for Aricept Patch NDA

25 Apr 2011
FDA approves Spectrum's FUSILEV Injection to treat metastatic colorectal cancer

FDA approves Spectrum's FUSILEV Injection to treat metastatic colorectal cancer

22 Apr 2011
Marinus initiates ganaxolone Phase 2 trial in posttraumatic stress disorder

Marinus initiates ganaxolone Phase 2 trial in posttraumatic stress disorder

22 Apr 2011

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