GlaxoSmithKline (GSK) and Theravance have withdrawn license application for the use of inhaled drug fluticasone furoate (FF) and vilanterol (VI), with proposed brand name of Relvar Ellipta, as treatment for chronic obstructive pulmonary ...
Tags: Japan, GSK, Relvar License
Janssen Research & Development is seeking FDA approval for use of ibrutinib in the treatment of previously treated patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL). The ...
Tags: FDA Approval, Janssen
The US FDA has accepted to review Bristol-Myers Squibb Company and Pfizer's Eliquis (apixaban) supplemental new drug application for prophylaxis of deep vein thrombosis (DVT) subsequent to hip or knee replacement surgery. The application ...
Tags: Drug Application, Medicine
US-based Mylan Pharmaceuticals has introduced generic equivalent to Micronor tablets, 0.35mg (28-day cycle) indicated for the prevention of pregnancy in the US. Norethindrone Tablets USP, 0.35mg, are the generic version of Janssen ...
Tags: Generic Micronor Tablets, Medicine
The FDA has approved the use of Astellas Pharma US' Mycamine (micafungin sodium) for injection to treat pediatric patients aged four months and more with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, ...
The USFDA has accepted Pfizer's supplemental new drug application (sNDA) to expand labeling of rheumatoid arthritis medication Xeljanz (tofacitinib citrate) to include inhibition of structural damage progression. The data from ORAL Start ...
Tags: FDA, Pfizer sNDA, Xeljanz Labeling
The US Food and Drug Administration (FDA) has accepted the new drug application (NDA)from DURECT, a specialty pharmaceutical company, for its Posidur (Saber-Bupivacaine) investigational candidate. Designed to offer up to three days of ...
Daiichi Sankyo Company is seeking approval for an oral antiplatelet agent prasugrel hydrochloride to treat ischemic heart diseased patients undergoing percutaneous coronary intervention (PCI) in Japan. The company has submitted a new drug ...
Tags: Daiichi Sankyo, Medicine
The US Food & Drug Administration (FDA) has issued a tentative approval letter to Supernus Pharmaceuticals for its Trokendi XR (extended release topiramate) in the treatment of epilepsy. Following to completion of review of the Trokendi ...
Tags: Supernus Trokendi, FDA Approval
Biopharmaceutical company Gilead Sciences has obtained priority review status for Sofosbuvir new drug application (NDA) from the FDA for the treatment of hepatitis C infection (HCV). The investigational product is an oral nucleotide ...
Tags: Gilead, Sofosbuvir NDA
The FDA has cleared Celgene's supplemental new drug application (sNDA) for Revlimid (lenalidomide) for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL). The approval follows positive data from MCL-001 phase ...
Specialty pharmaceutical company Sun Pharmaceutical Industries has obtained final USFDA approval for the abbreviated new drug application of generic Depo-Testosterone Injection, Testosterone Cypionate Injection USP, 100mg/ml and 200mg/ml. ...
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