FDA Approves AstraZeneca’s Imfinzi for Limited-Stage Small Cell Lung Cancer
AstraZeneca’s Imfinzi (durvalumab) has been approved in the United States for the treatment of adult patients with limited-stage small cell lung cancer.
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FDA Approves AstraZeneca’s Imfinzi for Limited-Stage Small Cell Lung Cancer
AstraZeneca’s Imfinzi (durvalumab) has been approved in the United States for the treatment of adult patients with limited-stage small cell lung cancer.
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Airsupra Rescue Inhaler Reduces Risk of Severe Asthma Exacerbations
AstraZeneca’s inhaled anti-inflammatory rescue medication demonstrated significant benefit compared to albuterol in a phase IIIb trial.
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Osimertinib Approved for Certain Stage III NSCLC Patients Following Chemoradiation
The FDA has approved osimertinib for adult patients with stage III NSCLC whose tumors have specific EGFR mutations, following chemoradiation therapy.
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FDA Approves Durvalumab-Chemo Combo for Resectable NSCLC
The approval was based on trial results which showed the regimen reduced the risk of recurrence, progression, or death by 32% versus neoadjuvant chemotherapy alone.
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Scientists Find Puzzling Immune Response to Adenoviral COVID Vaccines
The unexpected finding of pre-existing T-cell reactivity to the AstraZeneca and Janssen vaccines may explain why some people rarely developed thrombotic thrombocytopenia syndrome after vaccination.
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Positive Data for Tezspire in COPD Patients
New data presented at ATS 2024 show the potential of Tezspire to play a role in the future treatment of COPD.
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FDA Expands Use of Fasenra for Children Age 6 to 11
The additional indication is for pediatric patients aged 6-11 with severe eosinophilic asthma.
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AstraZeneca Sets $35 Monthly Cap on Inhaler Costs
Starting June 1, eligible patients will pay no more than $35 per month for all AstraZeneca US inhaled respiratory medicines.
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FDA-approved Anti-inflammatory Rescue Inhaler for Asthma Now Available
The inhaler contains a short-acting beta2-agonist to help relax the smooth muscles of the airways and an inhaled corticosteroid to help decrease inflammation in the lungs, treating both symptoms and inflammation.
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AAFA Applauds Senate Investigation into Asthma Inhaler Pricing
AAFA says the investigation opens an opportunity to address what patients report as the primary reason why people don’t adhere to their asthma treatment: the cost of prescribed asthma medication.
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Beyfortus Approved in China to Prevent RSV Infants
AstraZeneca and Sanofi’s Beyfortus (nirsevimab), a long-acting monoclonal antibody, has been approved in China for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in neonates and infants entering or during their first RSV season.
Read MoreAstraZeneca to Acquire Clinical-Stage Company Developing RSV, hMPV Combo Vaccine
The company’s lead investigational vaccine candidate, IVX-A12, is a potential first-in-class, phase III-ready vaccine targeting both RSV and human metapneumovirus.
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Benralizumab Reduces Need for Inhaled Steroids for Severe Asthma
Findings from a multinational study demonstrated that 92% of patients using benralizumab could safely reduce inhaled steroid dose, and more than 60% could stop all use.Â
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AstraZeneca’s NSCLC Therapy Imfinzi Misses Primary Endpoint in Ph3 Study
AstraZeneca’s Imfinzi (durvalumab) concurrently administered with chemoradiotherapy did not achieve a Phase 3 primary endpoint of progression-free survival versus CRT alone for the treatment of patients with unresectable, Stage III non-small cell lung cancer.
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Enhertu Approved in the EU for Certain NSCLC Patients
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) was approved in the EU as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.
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Datopotamab Deruxtecan Improved NSCLC Survival
AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan reduced the risk of disease progression or death by 25% in overall population and by 37% in patients with non-squamous tumors, according to Phase 3 trial data.
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CDC Recommendations for Nirsevimab Shortage
The US CDC has issued advice for healthcare providers to navigate the shortage of nirsevimab (Beyfortus), used to immunize infants from RSV.
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FDA Grants Priority Review to Tagrisso plus Chemotherapy for EGFR-mutated NSCLC
The FDA will review AstraZeneca’s sNDA for Tagrisso (osimertinib) plus chemotherapy for EGFRm non-small cell lung cancer (NSCLC).
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RSV Monoclonal Antibody in Short Supply
Sanofi issued an advisory to notify healthcare providers and consumers of a “unprecedented” and “higher than anticipated” demand for its recently-approved RSV monoclonal antibody, nirsevimab-alip (Beyfortus).
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FDA Approves RSV Shot for Infants
Beyfortus is the first preventive option approved to protect a broad infant population, including those born healthy at term, preterm, or with specific health conditions that make them vulnerable to severe RSV disease.
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Canada Approves RSV Immunization for Infants
The single-dose antibody drug can be used in babies during their first RSV season and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
Read MoreSingle-Dose RSV Shot for Infants Could Be Ready for Next Season
The target action date for the FDA’s approval decision is set for the third quarter. If approved, nirsevimab is expected to be available in the US for the 2023/2024 RSV season.
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FDA Approves Airsupra Asthma Rescue Inhaler
AstraZeneca’s Airsupra is the first FDA-approved combination of an inhaled corticosteroid and a short-acting beta-agonist for prevention of asthma exacerbations.
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AstraZeneca to Acquire Icosavax, in-development RSV-hMPV Combo Vaccine
AstraZeneca has entered into a definitive agreement to acquire Icosavax Inc and its combination vaccine candidate for RSV and hMPV.
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