The European Medicines Agency (EMA) has fully validated and granted accelerated assessment to Boehringer Ingelheim's application for European marketing authorization of faldaprevir, a potent second generation oral protease inhibitor. ...
Boehringer Ingelheim has submitted European marketing authorization applications (MAA) to extend the indication to use tiotropium (Spiriva) Respimat for the treatment of asthma in adults aged 18 years and over. The MAA is based on results ...
Janssen-Cilag (Janssen) has submitted a marketing authorization application to the European Medicines Agency (EMA) for the approval of a once-daily fixed-dose antiretroviral combination tablet of HIV-1 medicine darunavir with cobicistat. ...
Tags: European Marketing, HIV-1
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has confirmed its opinion for European marketing authorization of Pfizer's Xeljanz (tofacitinib citrate). Xeljanz is a novel, oral Janus kinase ...
CSL Behring's Privigen has obtained marketing authorization from the European Commission for use in chronic inflammatory demyelinating polyneuropathy (CIDP). Privigen is an immune globulin intravenous [human], 10% liquid, developed for ...
Tags: CSL Behring Privigen, European Marketing Authorization
Pfizer 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
The Food and Drug Administration (FDA) has accepted Dynavax Technologies' heplisav biologics license application (BLA) for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of ...
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
The European Commission (EC) has granted marketing authorization to Pfizer's INLYTA (axitinib) oral therapy, designed to treat adult patients with advanced renal cell carcinoma (RCC). INLYTA, a kinase inhibitor, is designed to ...
The European Commission has granted marketing authorization for AMAG Pharmaceuticals' intravenous iron therapy, ferumoxytol, to treat iron deficiency anemia (IDA) in chronic kidney disease (CKD) patients. The marketing authorization is ...
Tags: AMAG Pharmaceuticals, Intravenous Iron Therapy, chronic kidney disease
Boehringer Ingelheim and Eli Lilly and Company have received European Commission marketing authorization for Jentadueto (linagliptin/metformin hydrochloride) tablets. Jentadueto is a new, single-tablet treatment option, taken twice daily, ...
Tags: marketing authorization, Jentadueto tablets, glycemic control
Dynavax Technologies has submitted a US Biologics License Application (BLA) to the FDA for HEPLISAV, an investigational adult hepatitis B vaccine. In Phase III trials, HEPLISAV demonstrated higher and earlier protection with fewer ...