Daiichi Sankyo Company has filed a supplemental new drug application for extended indication of anticancer agent Topotecin intravenous drip infusion 40mg, 100mg with the Japan's Ministry of Health, Labor and Welfare. Topotecin intravenous ...
The USFDA has accepted Teva Pharmaceutical Industries' supplemental new drug application (sNDA) for reviewing Copaxone (glatiramer acetate injection) 40mg/1mL. Indicated for patients with relapsing-remitting multiple sclerosis (RRMS), the ...
Tags: Drug Application, Medicine
Sangamo BioSciences has received a $6.4m strategic partnership grant from the California Institute for Regenerative Medicine (CIRM) for the development of ZFP Therapeutic for Beta-thalassemia. The application of its zinc finger nuclease ...
Tags: Sangamo, ZFG Therapeutic
Mitsubishi Tanabe Pharma is seeking manufacturing and marketing approval of TA-7284 (generic name: canagliflozin) in Japan. The company filed a new drug application to the Ministry of Health, Labor and Welfare in Japan for TA-7284 to ...
Tags: Mitsubishi, canagliflozin
The US Food and Drug Administration (FDA) has cleared Omeros' investigational new drug application (IND) for OMS824 in Huntington's disease. OMS824 is developed to selectively inhibit phosphodiesterase 10 enzyme that is expressed in areas ...
Tags: Omeros'IND, Medicine
Celgene International has obtained FDA priority review status for Abraxane (paclitaxel protein-bound particles for injectable suspension) supplemental new drug application (sNDA). The application covers the use of Abraxane and gemcitabine ...
Tags: Celgene sNDA, FDA Priority
The US Food and Drug Administration (FDA) has cleared Oramed's investigational new drug (IND) application for ORMD-0801, an oral insulin capsule, allowing the company to begin clinical trials of the drug. ORMD-0801 is an orally ingestible ...
Tags: FDA, Oral Insulin Capsule
Mylan Pharmaceuticals, the subsidiary of Mylan, has introduced Fenofibrate tablets, 48 mg and 145 mg. The company has received the final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application ...
Tags: Mylan, Generic Version
TaiGen 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
The US FDA has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Zolmitriptan tablets, 2.5mg and 5mg. The generic equivalent of IPR Pharmaceuticals' Zomig tablets is indicated for the acute treatment of migraine ...
Tags: FDA, Pharmaceuticals
Taiwan-based specialty pharmaceutical company TWi Pharmaceuticals has obtained FDA tentative approval for its abbreviated new drug application (ANDA) for Guanfacine Hydrochloride Extended Release tablets 1mg, 2mg, 3mg and 4mg. The central ...
Tags: TWi, FDA, pharmaceutical
Think a pill that packs two cholesterol-lowering drugs in one potent package is a good idea? The Food and Drug Administration thinks so. It recently approved the combination of the popular statin drug Lipitor (atorvastatin) with another ...
GlaxoSmithKline (GSK) has submitted a new drug application (NDA) to the US FDA for umeclidinium bromide (UMEC) monotherapy 62.5mcg to treat chronic obstructive pulmonary disease (COPD). The investigational once-daily UMEC, administered ...
Tags: GlaxoSmithKline, FDA Approval, chronic obstructive pulmonary disease
Actavis has resolved outstanding patent litigation concerning generic version of Intuniv (guanfacine hydrochloride), indicated for the treatment of attention deficit hyperactivity disorder, with Shire. The settlement agreement also ...
GSK and Theravance have announced the submission of a regulatory application for Anoro Ellipta (UMEC/VI) (62.5/25mcg and 125/25mcg doses) in Japan. UMEC/VI combines a long-acting muscarinic antagonist (LAMA) GSK573719 or umeclidinium ...