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Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months in EGFR-mutated advanced lung cancer in FLAURA2 phase III trial – AstraZeneca

Written by | 18 Sep 2023

Positive results from the FLAURA2 Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS),… read more.

Complete Response for regulatory review of Ultomiris in the treatment of adult patients with neuromyelitis optica spectrum disorder – AstraZeneca

Written by | 15 Sep 2023

The FDA has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for long-acting C5 complement inhibitor Ultomiris (ravulizumab-cwvz) for the treatment of adult… read more.

Lynparza + abiraterone approved in Japan for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer – AstraZeneca + Merck Inc

Written by | 27 Aug 2023

AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisolone has been approved in Japan for the treatment of adult patients with BRCA-mutated (BRCAm) castration-resistant prostate cancer… read more.

Forxiga approved in China to reduce the risk of cardiovascular death and hospitalisation in adult patients with symptomatic chronic heart failure – AstraZeneca

Written by | 25 Aug 2023

Forxiga (dapagliflozin) from AstraZeneca. has been approved in China to reduce the risk of cardiovascular death, hospitalisation for heart failure (HF), or urgent HF visits in adults with… read more.

US CDC recommends Beyfortus for prevention of respiratory syncytial virus – Sanofi /AstraZeneca

Written by | 14 Aug 2023

The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously 10 to 0 to recommend routine use of Sanofi and AstraZeneca’s… read more.

Imfinzi + Imjudo demonstrated sustained overall survival benefit in advanced liver cancer with an unprecedented one in four patients alive at four years in HIMALAYA phase III trial – AstraZeneca

Written by | 13 Jul 2023

Updated results from the HIMALAYA Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) plus Imjudo (tremelimumab) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at four years for… read more.

Xigduo XR approved in China for adults with type-2 diabetes – AstraZeneca

Written by | 4 Jul 2023

AstraZeneca’s Xigduo XR (dapagliflozin and metformin hydrochloride extended-release), a once-daily fixed-dose combination, has been approved by China’s National Medical Products Administration (NMPA) for the treatment of adults with… read more.

Soliris approved in China for the treatment of adults with refractory generalised myasthenia gravis – AstraZeneca

Written by | 18 Jun 2023

Soliris (eculizumab) has been approved in China for the treatment of adult patients with refractory generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. Soliris is the… read more.

Lynparza + abiraterone approved in the US for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer – AstraZeneca + Merck Inc

Written by | 31 May 2023

AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been approved in the US for the treatment of adult patients with deleterious or… read more.

Saphnelo approved in the EU for the treatment of moderate to severe systemic lupus erythematosus – AstraZeneca

Written by | 2 Mar 2022

AstraZeneca’s Saphnelo (anifrolumab) has been approved in the European Union as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus… read more.

Tezspire is first biologic for severe asthma

Written by | 2 Jan 2022

The FDA approved the only biologic for severe asthma without any phenotype or biomarker limitations, manufacturers AstraZeneca and Amgen announced. The first-in-class biologic tezepelumab-ekko (Tezspire) is indicated as an… read more.

Enhertu reduced the risk of disease progression or death by 72% vs. trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer – AstraZeneca + Daiichi Sankyo

Written by | 28 Sep 2021

Ground-breaking Phase III head-to-head DESTINY-Breast03 results featured at ESMO Presidential Symposium support Enhertu as the potential new standard of care in previously treated patients. DESTINY-Breast01 Phase II trial… read more.

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