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AstraZeneca's Calquence sNDA Gets FDA Priority Tag for Expanded Use
AstraZeneca AZN announced that the FDA has accepted the supplemental new drug application (sNDA), seeking approval for the expanded use of Calquence (acalabrutinib) in mantle cell lymphoma (MCL).
AstraZeneca (LSE:AZN) Gains FDA Approval For Datroway In Treating Advanced Lung Cancer
AstraZeneca (LSE:AZN) recently announced the U.S. FDA accelerated approval of Datroway for treating advanced EGFR-mutated non ...
Business Insider2mon
AstraZeneca’s Calquence recommended for approval in EU for treatment of MCL
AstraZeneca’s Calquence in combination with bendamustine and rituximab has been recommended for approval in the European Union, EU, for the treatment of adult patients with previously untreated ...
pharmaphorum9d
Calquence approval another win for AstraZeneca in oncology
AstraZeneca has received another boost to its aspirations in oncology with the FDA approval of Calquence, a next generation treatment for mantle cell lymphoma (MCL). Calquence (acalabrutinib) is ...
FiercePharma6mon
ASH: AstraZeneca proposes fixed-duration Calquence combos in CLL
ASH: AstraZeneca proposes fixed-duration Calquence combos in chronic lymphocytic leukemia By Angus Liu Dec 8, 2024 11:00am AstraZeneca ASH 2024 Calquence chronic lymphocytic leukemia ...
Business Wire6mon
Fixed-duration CALQUENCE plus venetoclax demonstrated superior PFS vs. standard of care in previously untreated CLL, with 77% of patients progression free at ... - Business Wire
WILMINGTON, Del.--(BUSINESS WIRE)--Positive results from the AMPLIFY Phase III trial showed AstraZeneca’s CALQUENCE ® (acalabrutinib) in combination with venetoclax demonstrated a statistically ...
Pharmabiz19d
EU approves AstraZeneca’s Calquence in combo with venetoclax, with or without obinutuzumab to treat adult patients with previously untreated CLL
A fixed-duration regimen of AstraZeneca’s Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, has been approved in the European Union (EU) for the treatment of ...
Nasdaq11mon
Fixed-duration CALQUENCE® (acalabrutinib) plus venetoclax, with or without obinutuzumab, significantly improved progression-free survival in 1st-line chronic ... - Nasdaq
Positive high-level results from an interim analysis of the AMPLIFY Phase III trial showed a fixed duration of AstraZeneca’ s CALQUENCE ® in combination with venetoclax, with or without ...
Pharmabiz5mon
AstraZeneca’s Calquence plus chemoimmunotherapy approved in US for patients with previously untreated mantle cell lymphoma
AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab has been approved in the US for the treatment of adult patients with previously untreated mantle cell lymphoma ...
Yahoo Finance8mon
AstraZeneca's Calquence sNDA Gets FDA Priority Tag for Expanded Use - Yahoo Finance
AstraZeneca AZN announced that the FDA has accepted the supplemental new drug application (sNDA), seeking approval for the expanded use of Calquence (acalabrutinib) in mantle cell lymphoma (MCL).
pharmaphorum6d
Calquence approval another win for AstraZeneca in oncology
AstraZeneca has received another boost to its aspirations in oncology with the FDA approval of Calquence, a next generation treatment for mantle cell lymphoma (MCL). Calquence (acalabrutinib) is ...