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.
Tag: Astrazeneca
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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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Single-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.
Studies: Slightly Elevated Risk of Intracranial Thrombosis After AstraZeneca COVID-19 Vaccination
There is a slightly elevated risk of intracranial thrombosis events following vaccination with the AstraZeneca ChAdOx1-S COVID vaccine, according to two new studies published in Plos Medicine
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FDA Approves Generic Roflumilast for COPD
The FDA has approved a generic version of roflumilast manufactured by Zydus Pharmaceuticals USA Inc for the treatment of COPD.
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Positive Data for AstraZeneca COVID-19 Vaccine Booster
AstraZeneca reports that its COVID-19 vaccine (Vaxzevria), when given as a third dose booster, increased the immune response to Beta, Delta, Alpha and Gamma SARS-CoV-2 variants, while a separate analysis of samples from the trial showed increased antibody response to the Omicron variant.
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FDA OKs Tezspire for Severe Asthma
The FDA approved AstraZeneca and Amgen’s medication, Tezspire, to treat severe asthma for patients aged 12 years and older.
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Delta Variant May Evade Vaccine Immunity
Vaccines conferred protection from all COVID-19 variants but there was reduced antibody neutralization of both the Beta and Delta variants.
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AstraZeneca Long-Acting Monoclonal Antibodies Authorized
The FDA has issued an emergency use authorization for AstraZeneca’s Evusheld (tixagevimab and cilgavimab) to prevent COVID-19 in certain adults and children.
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AstraZeneca Monoclonal Antibody Effective as Preventative Therapy
AZD7442, a monoclonal antibody cocktail against the COVID-19 virus, reduced the risk of symptoms in a study of immunocompromised and chronically ill adults later exposed to the virus by 77%, according to AstraZeneca.
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Mixing AstraZeneca, Pfizer Jabs Offers Protection, Study Finds
The combination of AstraZeneca and Pfizer vaccines produce a strong immune response to the novel coronavirus, according to new research.
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Long-term Data Shows Safety, Effectiveness of Fasenra for Severe Eosinophilic Asthma
A five-year trial found at least 75% of Fasenra-treated asthma patients with elevated blood eosinophil levels had zero exacerbations each year of the open-label period.
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AstraZeneca Vax 76% Effective Overall, 100% Prevention of Severe Disease
New data released by AstraZeneca Thursday report its vaccine was 76% effective at overall prevention of symptomatic COVID-19, 85% effective in adults 65 and older, and 100% effective in preventing severe or critical disease and hospitalization.
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Safety Board Expresses ‘Concern’ Over AstraZeneca Vaccine Data
A Data & Safety Monitoring Board expressed concern that AstraZeneca may have included outdated information in a Phase 3 trial for its COVID-19 vaccine.
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AstraZeneca COVID-19 Vaccine 79% Effective in Adults
AstraZeneca says it will submit its COVID-19 vaccination for FDA authorization after phase 3 trial results found the vaccine to be 79% effective at preventing symptomatic COVID-19 and 100% effective at preventing severe disease and hospitalization.
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