New Drug Application News and Research

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Transcept Pharmaceuticals second-quarter net loss decreases to $2.06 million

Transcept Pharmaceuticals second-quarter net loss decreases to $2.06 million

Endo to acquire Penwest for $5.00 per share

Endo to acquire Penwest for $5.00 per share

Morphine plus oxycodone IV combination exhibits improved analgesia, tolerability compared to IV morphine

Morphine plus oxycodone IV combination exhibits improved analgesia, tolerability compared to IV morphine

FDA accepts Salix's XIFAXAN550 sNDA for Priority Review

FDA accepts Salix's XIFAXAN550 sNDA for Priority Review

Clinical Data first-quarter gross revenue increases 52% to $6.2 million

Clinical Data first-quarter gross revenue increases 52% to $6.2 million

Ironwood provides investor update for second-quarter 2010

Ironwood provides investor update for second-quarter 2010

EpiCept second-quarter net loss decreases to $4.9 million

EpiCept second-quarter net loss decreases to $4.9 million

ADVENTRX second-quarter net loss applicable to common stock increases to $5.0 million

ADVENTRX second-quarter net loss applicable to common stock increases to $5.0 million

Sucampo Pharmaceuticals second-quarter 2010 total revenue declines to $13.8 million

Sucampo Pharmaceuticals second-quarter 2010 total revenue declines to $13.8 million

FDA confirms Advisory Committee meeting date for lorcaserin NDA review

FDA confirms Advisory Committee meeting date for lorcaserin NDA review

Alkermes reports $42.3 million revenue for first-quarter fiscal 2011

Alkermes reports $42.3 million revenue for first-quarter fiscal 2011

Arena Pharmaceuticals to sell common stock shares to Deerfield Management

Arena Pharmaceuticals to sell common stock shares to Deerfield Management

FDA approves Lannett's ANDA for Ondansetron Injection

FDA approves Lannett's ANDA for Ondansetron Injection

Biovail second-quarter total revenues increase 23% to $238.8 million

Biovail second-quarter total revenues increase 23% to $238.8 million

Repligen total revenue for first-quarter fiscal 2011 increases 39% to $7.01 million

Repligen total revenue for first-quarter fiscal 2011 increases 39% to $7.01 million

Alexza to raise $18.0M in registered direct offering

Alexza to raise $18.0M in registered direct offering

Affymax, Takeda announce preliminary strategy for Hematide to treat anemia in chronic renal failure patients

Affymax, Takeda announce preliminary strategy for Hematide to treat anemia in chronic renal failure patients

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Lux Biosciences receives CRL for Voclosporin

Lux Biosciences receives CRL for Voclosporin

Anthera second-quarter total operating expenses increase to $7.9 million

Anthera second-quarter total operating expenses increase to $7.9 million

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