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fda - Articles and news items

Abeona enrols 5th patient in gene therapy Epidermolysis Bullosa trial

Industry news / 16 September 2016 / Niamh Louise Marriott, Digital Content Producer

EB-101 is the company’s lead gene therapy program for patients suffering with recessive dystrophic epidermolysis bullosa (RDEB), a severe form of…

UCB and Amgen submit FDA application for Osteoporosis drug

Industry news / 22 July 2016 / Niamh Louise Marriott, Digital Content Producer

UCB and Amgen today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for romosozumab, an investigational, monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture…

Continued and on-going process verification

Supplier news / 3 December 2015 / ChemAcademy

The FDA and EU published a lot of guidlines regarding process validation which makes it hard to keep up with all the changes…