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NDA submission
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Furiex Announced Top-Line Results Indicating The Two Pivotal Phase III Clinical Trials
Feb 14, 2014Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today announced top-line results indicating the company's two pivotal Phase III clinical trials evaluating the efficacy and safety of eluxadoline in the treatment of diarrhea-predominant irritable ...
Tags: Furiex
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Commercial Supply Agreement for Liquid Glucagon Rescue Device is declared by Biodel
Dec 19, 2013Biodel, a specialty pharmaceutical company, has announced a long-term supply agreement with Becton, Dickinson and Company, a medical technology company, for worldwide exclusive rights to the novel and proprietary BD Uniject SCF disposable ...
Tags: Biodel, Rescue Device
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JNJ and PCYC Have Won Approval From FDA for Their Breakthrough Therapy Imbruvica
Nov 15, 2013Johnson & Johnson (JNJ) subsidiary Janssen Biotech and Pharmacyclics (PCYC) have won approval from the US Food and Drug Administration (FDA) for their breakthrough therapy Imbruvica (ibrutinib) to treat patients with mantle cell lymphoma ...
Tags: Johnson&Johnson, MCL Patients
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FDA Has Accepted to Review AstraZeneca's New Drug Application for Epanova
Sep 20, 2013The US Food and Drug Administration (FDA) has accepted to review AstraZeneca's new drug application (NDA) for Epanova, an investigational compound for the treatment for patients with severe hypertriglyceridaemia. Omthera Pharmaceuticals, ...
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TaiGen Biotechnology Has Submitted New Drug Application
May 22, 2013TaiGen Biotechnology has submitted New Drug Application (NDA) for the oral formulation of nemonoxacin with the Taiwan Food and Drug Administration (TFDA) and China Food and Drug Administration (CFDA). Nemonoxacin is the first ...
Tags: TaiGen Biotechnology, Medicine
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The USFDA Has Accepted Otsuka Pharmaceutical's NDA of Tolvaptan for Priority
Apr 16, 2013The USFDA has accepted Otsuka Pharmaceutical's new drug application (NDA) of tolvaptan for priority review to treat autosomal dominant polycystic kidney disease (ADPKD). The filing was based on Phase III clinical trial results of the drug ...
Tags: Otsuka Tolvaptan NDA, Medicine
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FDA Has Accepted to Review Iroko Pharmaceuticals New Drug Application
Mar 8, 2013The US Food and Drug Administration (FDA) has accepted to review Iroko Pharmaceuticals New Drug Application (NDA) for lower dose submicron diclofenac, a non-steroidal anti-inflammatory drug (NSAID), with a proposed indication of treatment ...
Tags: FDA, Pharmaceuticals, Medicine
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Delcath Systems Has Submitted Chemosaturation System's NDA to The US FDA
Dec 18, 2012Delcath Systems has submitted its proprietary chemosaturation delivery system's new drug application (NDA) to the US Food and Drug Administration (FDA). The application includes the use of chemosaturation system along with melphalan ...
Tags: FDA, NDA, medical application
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The BZA/CE Is an Investigational Therapy Developed by Wyeth Pharmaceuticals
Dec 17, 2012Pfizer and Ligand Pharmaceuticals have announced the FDA acceptance of bazedoxifene/conjugated estrogens (BZA/CE) new drug application (NDA) for review. The BZA/CE is an investigational therapy developed by Wyeth Pharmaceuticals to tackle ...
Tags: estrogens NDA, Pharmaceuticals, FDA, menopausal symptoms
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Genzyme Submitted a New Drug Application to The FDA Seeking Approval for KYNAMRO
Dec 5, 2012Genzyme, a Sanofi company, has submitted a new drug application to the FDA seeking approval for KYNAMRO for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). The submission is based on trial in which ...
Tags: KYNAMRO, homozygous familial hypercholesterolemia, HoFH
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H. Lundbeck Have Submitted a New Drug Application
Dec 5, 2012Takeda Pharmaceutical Company and H. Lundbeck have submitted a new drug application (NDA) to the FDA for vortioxetine (Lu AA21004), an investigational drug for the treatment of major depressive disorder (MDD). Vortioxetine is under ...
Tags: Takeda Pharmaceutical Company, major depressive disorder, MDD
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FDA Has Accepted Geno's Filing of NDA for MVG
Nov 27, 2012The US Food and Drug Administration (FDA) has accepted GeNO's filing of new drug application (NDA) for GeNOsyl MVG-2000 nitric oxide delivery system. GeNOsyl nitric oxide is a vasodilator which is indicated for the treatment of term and ...
Tags: GeNOsyl nitric oxide, FDA
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FDA Accepted to Review Ferring Pharmaceuticals' NDA for Review
Oct 24, 2012The US Food and Drug Administration (FDA) has accepted to review Ferring Pharmaceuticals' new drug application (NDA) of controlled release misoprostol vaginal insert (MVI) for decreasing time to vaginal delivery in women with an unfavorable ...
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Raptor Pharmaceutical Has Announced FDA Acceptance of New Drug Application
Jun 14, 2012Raptor Pharmaceutical has announced FDA acceptance of new drug application (NDA) for Cysteamine Bitartrate delayed-release capsules (RP103) for the potential treatment of nephropathic cystinosis. RP103 gained standard review designation ...
Tags: nephropathic cystinosis, FDA acceptance, NDA submission
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GSK Have Announced The Submission of a New Drug Application
Apr 30, 2012Genmab and GlaxoSmithKline (GSK) have announced the submission of a new drug application (NDA) for Arzerra (ofatumumab) to the Japanese Ministry of Health, Labor and Welfare (MHLW). Arzerra (ofatumumab) is submitted for the approval ...
Tags: new drug application, Arzerra, chronic lymphocytic leukemia