Astellas Pharma and Medivation have announced the submission of marketing authorization application (MAA) to the European Medicines Agency (EMA) for enzalutamide to treat metastatic castration-resistant prostate cancer in men who have ...
Tags: enzalutamide, metastatic castration-resistant prostate cancer
Janssen Research & Development has announced that it has submitted a supplemental New Drug Application to FDA for ZYTIGA(abiraterone acetate). Janssen-Cilag International NV has also sent a type II variation to the European Medicines ...
The Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has recommended Orphan Drug Designation (ODD) for Erytech Pharma's investigational product Enhoxy. The drug, which is used to treat sickle cell ...
Tags: orphan drug designation, Erytech product, debilitating disease
Raptor Pharmaceutical has announced FDA acceptance of new drug application (NDA) for Cysteamine Bitartrate delayed-release capsules (RP103) for the potential treatment of nephropathic cystinosis. RP103 gained standard review designation ...
Tags: nephropathic cystinosis, FDA acceptance, NDA submission
The European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Vertex Pharmaceuticals' Kalydeco (ivacaftor) to treat the underlying cause of cystic fibrosis (CF). Kalydeco is indicated for people ...
Tags: Kalydeco, cystic fibrosis, clinical study