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
Astellas Pharma and Medivation have announced the submission of application for marketing approval of enzalutamide in Japan for the treatment of prostate cancer. The application was filed by Astellas with the Ministry of Health, Labour ...
Tags: Astellas, Marketing Application
Oncology-focused company Curis has announced the approval of Erivedge (vismodegib) in Australia for the treatment of metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma in adult patients who are not suitable for ...
Tags: Curis, Erivedge Anti-Cancer Drug
Lupin Pharmaceuticals has obtained final marketing approval from FDA for its Daysee tablets (Levonorgestrel and Ethinyl Estradiol Tablets, USP, 0.15mg/0.03mg and Ethinyl Estradiol Tablets, USP, 0.01mg). The company commenced the shipment ...
Eisai's subsidiary Eisai Laboratorios has submitted a marketing authorization application (MAA) for Belviq (lorcaserin HCl) with the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico. Arena Pharmaceuticals's ...
Tags: Eisai, Mexican Marketing, Belviq
California-based medical device Harbor MedTech has gained FDA marketing approval for its first product, Architect, an advanced collagen matrix for treatment of partial and full thickness skin wounds. Harbor president and founder Jerry ...
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Gilead Sciences' marketing authorization application (MAA) for stribild. The once-daily, single tablet regimen ...
Tags: Stribild drug, Medicines, Medicine
The US Food and Drug Administration (FDA) has accepted Neos Therapeutics' new drug application (NDA) 505(b)(2) filing for NT0202, an extended release (XR) orally disintegrating tablet (ODT) formulation of Amphetamine Polistirex. The ...
Biogen Idec is seeking marketing approval from the US Food and Drug Administration (FDA) for recombinant factor VIII Fc fusion protein (rFVIIIFc) therapy to treat hemophilia A. The company has submitted a biologics license application ...
Tags: Biogen Idec, FDA, hemophilia A
The US Food and Drug Administration (FDA) has accepted Biogen Idec's biologics license application (BLA) for the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of hemophilia B. Using the company's ...
Tags: FDA, Idec BLA, hemophilia B
Biopharmaceutical and diagnostics company OPKO Health has acquired Brazilian pharmaceutical company Silcon Comércio, Importacao E Exportacao de Produtos Farmaceuticos e Cosmeticos. The acquisition is expected to expand OPKO's ...
Tags: OPKO Health, Silcon, Biopharmaceutical
The USFDA has issued final approval to manufacture and market Aurobindo Pharma's diabetes drugs, Pioglitazone tablets and Pioglitazone Hydrochloride + Metformin Hydrochloride tablets. Pioglitazone Tablets USP 15mg, 30mg & 45mg and ...
Tags: USFDA, Aurobindo Pharma, diabetes drugs
The US FDA has issued marketing approval for Lupin Pharmaceuticals' Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.1mg / 0.02mg, the combined oral contraceptive. Levonorgestrel and Ethinyl Estradiol Tablets are the generic equivalent ...
Tags: FDA, Oral Contraceptive Medication, Lupin Pharmaceuticals
Japan Tobacco (JT), Keryx Biopharmaceuticals' Japanese partner, has filed a new drug application (NDA) for the marketing approval of Ferric Citrate (Zerenex) in Japan for the treatment of hyperphosphatemia in chronic kidney disease (CKD) ...
Tags: Ferric Citrate, Tobacco, CKD, Pharmaceutical
Gilead Sciences, a biopharmaceutical company, has submitted a new drug application (NDA) to the FDA for HIV integrase inhibitor elvitegravir for the treatment-experienced patients. The company provided 96-week data from a pivotal Phase ...