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Tezepelumab Granted Priority Review By U.S. FDA drugs
July 15, 2021
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma.
FDA grants priority review to BLA for AstraZeneca-Amgen’s tezepelumab pharmaceutical-technology
July 09, 2021
The US Food and Drug Administration (FDA) has granted priority review to biologics license application (BLA) for AstraZeneca and Amgen’s experimental drug, tezepelumab, for asthma treatment.
Tezepelumab significantly reduces exacerbations of severe asthma europeanpharmaceuticalreview
March 02, 2021
In a Phase III trial, tezepelumab was shown to meaningfully reduce annualised asthma exacerbation rates in a range of patients with severe, uncontrolled asthma.
Tezepelumab Trial Does Not Meet Primary Endpoint americanpharmaceuticalreview
January 08, 2021
Amgen and AstraZeneca announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo.
AZ, Amgen’s SOURCE trial misses primary endpoint pharmatimes
December 23, 2020
AstraZeneca and Amgen have announced that a phase III trial of their new medicine tezepelumab failed to meet the primary endpoint in patients with severe, oral corticosteroid-dependent asthma.
Tezepelumab Trial Meets Primary Endpoint americanpharmaceuticalreview
November 20, 2020
Amgen and AstraZeneca announced positive topline results from the Phase 3 NAVIGATOR trial in which the investigational medicine tezepelumab demonstrated a statistically significant reduction in exacerbations compared to placebo in patients with severe ...
Amgen, AZ’s asthma drug tezepelumab scores phase III win pharmatimes
November 12, 2020
Amgen and AstraZeneca’s (AZ) experimental asthma drug tezepelumab has scored a phase III win in severe, uncontrolled asthma.
AstraZeneca and Amgen receive breakthrough status for tezepelumab September 11, 2018
AstraZeneca and Amgen have received breakthrough therapy designation for tezepelumab to treat severe asthma, irrespective of an eosinophilic phenotype.
Tezepelumab granted Breakthrough Therapy Designation by US FDA worldpharmanews
September 10, 2018
AstraZeneca and its partner Amgen Inc. (Amgen) today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma
Tezepelumab significantly reduced asthma exacerbations for a broad population of patients with sever worldpharmanews
September 07, 2017
AstraZeneca and Amgen Inc. (Amgen) announce results from the PATHWAY Phase IIb trial of tezepelumab that showed a significant reduction in the annual asthma exacerbation rate compared with placebo in patients with severe,