Janssen Research & Development has submitted a New Drug Application (NDA) to the US FDA seeking approval for a fixed-dose therapy combining canagliflozin and immediate release metformin to treat patients with type 2 diabetes. ...
Takeda Global Research & Development Center and Lundbeck have announced the FDA acceptance of vortioxetine new drug application (NDA) filing for major depressive disorder. The companies have also announced the proposal of Brintellix as ...
Tags: FDA, new drug application, NDA
US based NuPathe announced that its New Drug Application (NDA) resubmission for its migraine patch (NP101) has been accepted for filing by the US Food and Drug Administration (FDA). Migraine Patch (NP101 or Zelrix) is an active, ...
Tags: FDA, NuPathe, migraine patch, NDA
Teva Women's Health, a US-based subsidiary of Teva Pharmaceutical Industries, has announced FDA acceptance of its Quartette new drug application (NDA). The company is seeking approval to manufacture and market Quartette ...
Tags: ethinyl estradiol tablets, market Quartette, contraceptive products
The Antiviral Drugs Advisory Committee of the FDA has recommended the approval of Gilead's Quad to treat HIV-1 infection in treatment-naive adults. The Quad is a complete single tablet regimen of elvitegravir, cobicistat, emtricitabine ...
Tags: gilead's quad, HIV-1, quad NDA
US based Ariad Pharmaceuticals has submitted New Drug Application (NDA) for its investigational BCR-ABL inhibitor, ponatinib for the approval of US Food and Drug Administration (FDA). Ponatinib is indicated for patients with resistant or ...
Tags: BCR-ABL inhibitor, CML, Ph+ALL
A new milk processing plant has been opened in Malungon province in Sarangani, Philippines, which is expected to strengthen the diary industry in the area and provide income for dairy farmers. The project has been funded by Land O` Lakes ...
Tags: milk processing plant, diary industry, income for dairy farmers
Genzyme, 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
The FDA has accepted the review of Zogenix new drug application (NDA) for Zohydro ER (hydrocodone bitartrate extended-release capsules) for the treatment of moderate to severe chronic pain. Zohydro ER is an oral, single-entity (without ...
Tags: Zohydro ER, hydrocodone bitartrate extended-release capsules
Bayer HealthCare has filed a new drug application (NDA) with the FDA seeking approval for the oral multi-kinase inhibitor regorafenib to treat patients with metastatic colorectal cancer (mCRC). The company has even filed an application ...
Tags: oral multi-kinase inhibitor regorafenib, metastatic colorectal cancer
Janssen-Cilag International has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) seeking conditional approval to use the investigational drug bedaquiline (TMC207) as an oral treatment, to be used as ...
Tags: investigational drug bedaquiline, multi-drug resistant tuberculosis
Takeda 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
Furiex Pharmaceuticals said Takeda Global Research & Development Center has resubmitted New Drug Applications (NDAs) to the US Food and Drug Administration (FDA) for alogliptin and fixed-dose combination therapy alogliptin and pioglitazone ...
Tags: Furiex Pharmaceuticals, NDAs, alogliptin and pioglitazone
Janssen Research & Development has submitted a new drug application (NDA) to the FDA for canagliflozin to treat adult patients with type 2 diabetes. The filing is based on a global Phase III clinical development program, including nine ...
Tags: Janssen Research&Development, SGLT2, cardiovascular study
Supernus Pharmaceuticals has received approval from the FDA for its Oxtellar XR, a new once-daily extended release formulation of oxcarbazepine. Oxtellar XR is an antiepileptic drug used as an adjunct therapy to treat partial seizures in ...
Tags: oxcarbazepine, FDA approval, partial seizure, pharmaceutical product