US FDA grants Breakthrough Therapy Designation
5 February 2019 07:05 GMT US FDA grants Breakthrough Therapy Designationfor potential next-generation RSV medicine MEDI8897 Designation based on positive primary analysis of the Phase IIbtrial that demonstrated the safety and efficacy of MEDI8897 AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for MEDI8897, an extended half-life respiratory syncytial virus (RSV) F monoclonal antibody (mAb) being developed for the prevention of lower