The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on FINOX Biotech's marketing authorisation application (MAA) for BEMFOLA (follitropin alfa solution for injection in ...
Janssen-Cilag (Janssen), a subsidiary of Johnson & Johnson pharmaceutical firm, has submitted marketing authorization application (MAA) to the European Medicines Agency (EMA) for the approval of once daily oral drug ibrutinib for the ...
Tags: Blood Cancer Medicine, Medicine
Boehringer Ingelheim has submitted a marketing authorisation application to the European Medicines Agency (EMA) for the approval of its oral triple angiokinase inhibitor nintedanib. Nintedanib to be used in combination with docetaxel is ...
Tags: Boehringer Ingelheim, Lung Cancer
British drugmaker GlaxoSmithKline (GSK) has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for its cervical cancer vaccine, Cervarix [Human papillomavirus bivalent (types 16 and 18) vaccine, ...
Tags: Cervarix, Schedule Application
Biogen has announced acceptance of marketing applications of Plegridy(peginterferon beta-1a) for review by the US and EU regulatory authorities. Plegridy, a member of the interferon class of treatments, is a pegylated subcutaneous ...
Tags: Biogen, Marketing Applications
The European Medicines Agency (EMA) has accepted Eli Lilly and Company and Boehringer Ingelheim's marketing authorisation application (MAA) for a new insulin glargine product, LY2963016, for review. The application has been filed through ...
Biogen Idec is seeking FDA approval for Plegridy (Peginterferon Beta-1a) as multiple sclerosis (MS) medication. The company submitted a biologics license application (BLA) to the FDA for its pegylated subcutaneous injectable candidate ...
Tags: Biogen IDEC, FDA Approval
The European Medicines Agency (EMA) has accepted Shionogi's marketing authorisation application (MAA) for ospemifene. Ospemifene is developed as as vulvar and vaginal atrophy (VVA) therapy in post-menopausal women. Shionogi CEO Takashi ...
Tags: EMA, Medicines, ospemifene
Takeda Pharmaceutical Company has submitted marketing authorisation application (MAA) seeking approval from the European Medicines Agency (EMA) for its investigational, gut-selective humanized monoclonal antibody for the treatment of adults ...
Tags: Takeda, IBD Disease Drug, MAA, EMA
The USFDA has granted priority review designation to ViiV Healthcare's dolutegravir as a candidate with the potential to treat HIV infection in combination with other antiretroviral agents, in adolescents and adults. The dolutegravir new ...
Tags: infection therapy, Healthcare, FDA
GlaxoSmithKline (GSK) has submitted marketing authorisation application, to the European Medicines Agency, for trametinib (MEK) as monotherapy and dabrafenib (BRAF)/MEK combination therapy in metastatic melanoma. The application was ...
Tags: GSK, metastatic melanoma therapy, Medicines
FINOX Biotech has submitted the Marketing Authorisation Application (MAA) for its biosimilar recombinant Follicle Stimulating Hormone (r-FSH) BEMFOLA to the European Medicines Agency. The submission was based on a comprehensive clinical ...
Tags: FINOX Biotech, Marketing Authorisation Application, Medicines, healthcare
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
Ferrer Internacional has decided to withdraw the marketing authorisation application (MAA) for Egrifta (tesamorelin) 2mg, powder for solution for injection in Europe. Ferrer formally notified the European Medicines Agency of its decision. ...
Tags: DME, healthcare products, pSivida
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended SkyePharma's flutiform (fluticasone propionate/formoterol fumarate) for European marketing approval. Flutiform is a ...
Tags: Skyepharma Flutiform, SkyePharma, long-acting beta-agonist