Salix Pharmaceuticals and Pharming Group have announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) Action Date to 16 July 2014 for the Biologics License Application (BLA) for the ...
Tags: Drug, Pharming Group
Discovery Laboratories, a specialty biotechnology company dedicated to advancing a new standard of respiratory critical care, has announced that the US Food and Drug Administration (FDA) has cleared the company's investigational new drug ...
Tags: Discovery Labs, Medicine
Pharming Group and Santarus have announced the submission of Ruconest (recombinant human C1 esterase inhibitor) biologics license application to the FDA. Investigational drug Ruconest 50 U/kg is being developed for the treatment of acute ...
Merck, referred to as MSD outside the US and Canada, and Luminex have signed a deal to develop a companion diagnostic device to support patient selection for the clinical development program of investigational drug MK-8931 to treat ...
Tags: companion diagnostic device, drug, Merck
The US Food and Drug Administration (FDA) has accepted Avanir Pharmaceuticals' investigational new drug (IND) application for the study of AVP-923, an investigational drug for the treatment of agitation in patients with Alzheimer's disease. ...
Tags: AVP-923, Alzheimer's disease, IND
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
Takeda Pharmaceutical Company and H. Lundbeck have submitted a new drug application (NDA) to the FDA for vortioxetine (Lu AA21004), an investigational drug for the treatment of major depressive disorder (MDD). Vortioxetine is under ...
Tags: Takeda Pharmaceutical Company, major depressive disorder, MDD
Janssen Research & Development company has submitted bedaquiline (TMC207) new drug application (NDA) to the US Food and Drug Administration (FDA) for approval. Bedaquiline,an investigational drug administered orally,is used as part of ...
Tags: FDA, new drug application, investigational drug, pulmonary
Biogen Idec (BIIB) and Isis Pharmaceuticals have entered into an exclusive, worldwide option and collaboration agreement, pursuant to which the companies will develop and commercialize a novel antisense drug for the treatment of myotonic ...
Tags: Steinert Disease, antisense drug