New Drug Application News and Research

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FDA approves Perrigo’s NDA for testosterone gel 1%

FDA approves Perrigo’s NDA for testosterone gel 1%

5 Feb 2013
Merck full-year 2012 worldwide sales decrease 2% to $47.3 billion

Merck full-year 2012 worldwide sales decrease 2% to $47.3 billion

1 Feb 2013
ArQule, Daiichi Sankyo initiate enrollment in tivantinib Phase 3 trial for hepatocellular carcinoma

ArQule, Daiichi Sankyo initiate enrollment in tivantinib Phase 3 trial for hepatocellular carcinoma

31 Jan 2013
Top-line results from Vanda's tasimelteon Phase IIb/III study on major depressive disorder

Top-line results from Vanda's tasimelteon Phase IIb/III study on major depressive disorder

31 Jan 2013
Keryx prices underwritten public offering of common stock

Keryx prices underwritten public offering of common stock

30 Jan 2013
Foresee, ScinoPharm to form joint venture for new oncological Leuprolide injectable drug

Foresee, ScinoPharm to form joint venture for new oncological Leuprolide injectable drug

30 Jan 2013
FDA approves Genzyme’s KYNAMRO to treat homozygous familial hypercholesterolemia

FDA approves Genzyme’s KYNAMRO to treat homozygous familial hypercholesterolemia

30 Jan 2013
Meridian reports positive pre-IND meeting with FDA for ML061

Meridian reports positive pre-IND meeting with FDA for ML061

29 Jan 2013
Amneal enters license and distribution agreement with Hanmi for generic Nexium

Amneal enters license and distribution agreement with Hanmi for generic Nexium

28 Jan 2013
Gilead commences first of two tenofovir alafenamide Phase 3 trials in HIV

Gilead commences first of two tenofovir alafenamide Phase 3 trials in HIV

28 Jan 2013
FDA approves Takeda’s NESINA, OSENI and KAZANO for treatment of type 2 diabetes

FDA approves Takeda’s NESINA, OSENI and KAZANO for treatment of type 2 diabetes

28 Jan 2013
Neuromuscular blockade (NMB) reversal

Neuromuscular blockade (NMB) reversal

24 Jan 2013
Clinical trial to evaluate cyclodextrin against Niemann-Pick disease type C1

Clinical trial to evaluate cyclodextrin against Niemann-Pick disease type C1

24 Jan 2013
Actavis seeks FDA approval to market generic Opana ER

Actavis seeks FDA approval to market generic Opana ER

23 Jan 2013
QrxPharma to resubmit MOXDUO NDA with FDA

QrxPharma to resubmit MOXDUO NDA with FDA

17 Jan 2013
Boehringer Ingelheim receives FDA Priority Review for afatinib to treat EGFR mutation-positive NSCLC

Boehringer Ingelheim receives FDA Priority Review for afatinib to treat EGFR mutation-positive NSCLC

17 Jan 2013
Astellas announces FDA acceptance of Tarceva sNDA for EGFR activating mutation-positive NSCLC

Astellas announces FDA acceptance of Tarceva sNDA for EGFR activating mutation-positive NSCLC

17 Jan 2013
GE Healthcare submits Optison sNDA to aid in detection of cardiovascular diseases

GE Healthcare submits Optison sNDA to aid in detection of cardiovascular diseases

16 Jan 2013
Update on Cytos’ CYT003 Phase 2b trial for allergic asthma

Update on Cytos’ CYT003 Phase 2b trial for allergic asthma

16 Jan 2013
Orexigen reports progress with FDA on faster path to Contrave NDA resubmission

Orexigen reports progress with FDA on faster path to Contrave NDA resubmission

9 Jan 2013

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