Tag Archives: 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 reduced asthma exacerbations compared to placebo in severe asthma CAMBRIDGE, 12-Sep-2018 — /EuropaWire/ — AstraZeneca and its partner Amgen Inc. (Amgen) … Read the full press release

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, ROG; OTCQX: RHHBY) announced today that it has received a second Breakthrough Therapy Designation from the United States Food and … Read the full press release

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 potential to be the first treatment for sIBM patients BYM338 is the third Novartis investigational treatment this year to receive … Read the full press release