breakthrough therapy designation

AstraZeneca and Amgen announce US FDA Breakthrough Therapy Designation for tezepelumab in patients with severe asthma

AstraZeneca’s first Breakthrough Therapy Designation for a respiratory medicine Designation based on Phase IIb PATHWAY data that demonstrated tezepelumab significantly…

6 years ago

Roche received second Breakthrough Therapy Designation from FDA for its investigational cancer immunotherapy MPDL3280A (anti-PDL1)

Second FDA Breakthrough Therapy Designation for MPDL3280A following bladder cancer in 2014 BASEL, 3-2-2015 — /EuropaWire/ — Roche (SIX: RO,…

9 years ago

US FDA granted breakthrough therapy designation to Novartis’s BYM338 for sporadic inclusion body myositis

Designation highlights potential of BYM338 to address an unmet medical need in a serious disease If approved, BYM338 has the…

11 years ago