AstraZeneca

ASTRAZENECA NEWSROOM (172 press releases)

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AstraZeneca and Daiichi Sankyo’s Enhertu-based regimen shows 44% risk reduction and over three-year PFS in HER2-positive metastatic breast cancer

PRESS RELEASE -- 24, September 2025

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application for Enhertu plus pertuzumab has been accepted for Priority Review by the FDA for the first-line treatment of HER2-positive metastatic breast cancer. The application is supported by data from the … Read the full press release

Alfa Laval brings global industry and academia together in Lund for ESS Innovation Day 2025 on neutron science applications

PRESS RELEASE -- 20, August 2025

(IN BRIEF) Alfa Laval is hosting ESS Innovation Day 2025 on 19 August in Lund, Sweden, an event that unites research directors from leading companies and universities to explore how neutron science from the European Spallation Source (ESS) can help … Read the full press release

FDA Grants Priority Review to Imfinzi for First‑Ever Perioperative Immunotherapy in Resectable Gastric and GEJ Cancer

PRESS RELEASE -- 28, July 2025

(IN BRIEF) The FDA has accepted AstraZeneca’s sBLA for Imfinzi as a perioperative immunotherapy regimen in resectable early‑stage and locally advanced gastric and GEJ cancers, granting Priority Review with a decision expected in Q4 2025. The application leverages MATTERHORN Phase III data … Read the full press release

EMA Supports AstraZeneca’s Eco-Friendly Trixeo Aerosphere for COPD with Ultra-Low Emission Propellant

PRESS RELEASE -- 25, July 2025

(IN BRIEF) AstraZeneca’s Trixeo Aerosphere has received a positive opinion from the EMA’s CHMP for use with a new propellant that offers a 99.9% reduction in Global Warming Potential compared to traditional formulations. Trixeo becomes the first pressurised metered-dose inhaler … Read the full press release

Final FLAURA2 Results Confirm Survival Advantage of Tagrisso Plus Chemotherapy in Advanced EGFRm Lung Cancer

PRESS RELEASE -- 21, July 2025

(IN BRIEF) Final overall survival results from AstraZeneca’s FLAURA2 Phase III trial confirm that combining Tagrisso with chemotherapy significantly improves survival for patients with first-line advanced EGFR-mutated NSCLC. The data reinforce Tagrisso as the foundational therapy in this setting, building … Read the full press release

Imfinzi Regimen Cuts Recurrence Risk by a Third and Boosts Two-Year Survival in Bladder Cancer

PRESS RELEASE -- 4, July 2025

(IN BRIEF) The European Commission has approved AstraZeneca’s Imfinzi (durvalumab) combined with gemcitabine and cisplatin as neoadjuvant therapy, followed by Imfinzi adjuvant monotherapy, for adults with resectable muscle-invasive bladder cancer. This approval is anchored in NIAGARA Phase III trial data … Read the full press release

ESC Leads Key Work Packages in €27 M EuroHeartPath Project to Redesign Cardiovascular Care Across 15 EU States

PRESS RELEASE -- 17, June 2025

(IN BRIEF) From its leadership of key work packages to its rich data resources—the ESC Atlas of Cardiology and GRASP study—the European Society of Cardiology is driving EuroHeartPath’s mission to transform heart-disease care in Europe. This €27 million Horizon Europe … Read the full press release

Sanofi Begins Early Global Distribution of Beyfortus to Strengthen RSV Protection for 2025–2026 Season

PRESS RELEASE -- 9, June 2025

(IN BRIEF) Sanofi has launched early global shipments of Beyfortus (nirsevimab) in anticipation of the 2025–2026 RSV season, enabling healthcare providers to begin immunizations well before the typical onset of infections in November. In collaboration with AstraZeneca, Sanofi has significantly … Read the full press release

AstraZeneca’s Calquence Combination Therapy Approved for Untreated CLL in Europe Following Positive AMPLIFY Phase III Results

PRESS RELEASE -- 7, June 2025

(IN BRIEF) AstraZeneca’s Calquence, in combination with venetoclax, with or without obinutuzumab, has been approved by the European Commission for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). The approval follows the positive results from the … Read the full press release

AstraZeneca’s Imfinzi Plus BCG Induction and Maintenance Therapy Significantly Improves Disease-Free Survival in High-Risk Non-Muscle-Invasive Bladder Cancer

PRESS RELEASE -- 9, May 2025

(IN BRIEF) The POTOMAC Phase III trial results show that adding Imfinzi to standard BCG induction and maintenance therapy improves disease-free survival (DFS) for patients with high-risk non-muscle-invasive bladder cancer (NMIBC). The combination demonstrated significant benefits over BCG alone, with … Read the full press release

AstraZeneca’s Breztri Aerosphere Shows Positive Phase III Results for Uncontrolled Asthma Treatment

PRESS RELEASE -- 2, May 2025

(IN BRIEF) Positive results from the Phase III KALOS and LOGOS trials show that AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) significantly improves lung function in patients with uncontrolled asthma, compared to dual-combination ICS/LABA therapy. The trials demonstrate the potential of Breztri … Read the full press release

AstraZeneca Unveils Breakthrough Data on Vaccines and Antibody Therapies for Infections

PRESS RELEASE -- 8, April 2025

(IN BRIEF) At ESCMID Global 2025 in Vienna, AstraZeneca will present a comprehensive data package from its Vaccines & Immune Therapies portfolio, featuring 13 abstracts across oral and poster presentations. The Company aims to demonstrate its progress in developing innovative … Read the full press release

Novo Nordisk Revamps Executive Team: New Leadership Roles Set to Drive Global Strategy

PRESS RELEASE -- 3, April 2025

(IN BRIEF) Effective 3 April 2025, Novo Nordisk will undergo key changes in its Executive Management. Camilla Sylvest, a long-time leader with 28 years at the company, has decided to step down. In response, Ludovic Helfgott will assume expanded responsibilities … Read the full press release

MATTERHORN Trial Shows Perioperative Immunotherapy Significantly Enhances Survival in Gastric and GEJ Cancer Patients

PRESS RELEASE -- 7, March 2025

(IN BRIEF) The MATTERHORN Phase III trial has demonstrated that a perioperative regimen combining AstraZeneca’s Imfinzi (durvalumab) with FLOT chemotherapy significantly improves event-free survival in patients with resectable gastric and gastroesophageal junction cancers compared to standard chemotherapy alone. Interim findings … Read the full press release

Alexion and DHL Express Lead with 100% Transition to Sustainable Aviation Fuel in Europe

PRESS RELEASE -- 12, February 2025

(IN BRIEF) Alexion, AstraZeneca Rare Disease, has partnered with DHL Express to become the first company in Ireland to fully transition its air freight operations to 100% Sustainable Aviation Fuel (SAF). This switch will reduce greenhouse gas emissions by over … Read the full press release

Patients as Partners® Europe Launches the 9th Annual Event with 2025 Keynotes, Featured Speakers and Topics

PRESS RELEASE -- 11, February 2025

(IN BRIEF) The Conference Forum has announced the 9th annual Patients as Partners® Europe event, scheduled for May 20-21, 2025, at the Royal National Hotel in London. This event offers a platform for pharma R&D and patient advocacy to discuss … Read the full press release

AstraZeneca’s Imfinzi Recommended for EU Approval as Breakthrough Treatment for Limited-Stage Small Cell Lung Cancer

PRESS RELEASE -- 4, February 2025

(IN BRIEF) AstraZeneca’s Imfinzi (durvalumab) has received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for approval as a monotherapy to treat limited-stage small cell lung cancer (LS-SCLC) in patients whose disease … Read the full press release

AstraZeneca’s Calquence Gains U.S. Approval for First-Line Treatment of Mantle Cell Lymphoma, Following Positive Phase III Results

PRESS RELEASE -- 18, January 2025

(IN BRIEF) AstraZeneca’s Calquence (acalabrutinib) has been approved by the U.S. FDA for the first-line treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation. The approval is based on … Read the full press release

FDA Grants Priority Review for AstraZeneca and Daiichi Sankyo’s Datopotamab Deruxtecan for EGFR-Mutated Lung Cancer

PRESS RELEASE -- 13, January 2025

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan has been accepted by the U.S. FDA for treating advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) in patients who have previously received systemic therapies. The … Read the full press release

AstraZeneca’s Imfinzi Granted Priority Review by FDA for Groundbreaking Perioperative Immunotherapy in Bladder Cancer

PRESS RELEASE -- 7, December 2024

(IN BRIEF) AstraZeneca’s Imfinzi (durvalumab) has been granted Priority Review by the FDA for the treatment of muscle-invasive bladder cancer (MIBC), potentially becoming the first perioperative immunotherapy in this curative-intent setting. Supported by results from the NIAGARA Phase III trial, … Read the full press release