FDA Authorizes Novavax COVID Vaccine
The FDA issued an emergency use authorization for the Novavax COVID vaccine (adjuvanted) for Americans 18 years of age and older.
Tag: pharmaceuticals
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Tezepelumab Improved Severe Asthma in Half of Patients
A greater proportion of patients with severe, uncontrolled asthma had more significant clinical responses to tezepelumab (Tezspire) than placebo, according to research presented at ATS 2022.
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FDA Expands Approval of Remdesivir for Pediatric Patients
The US FDA expanded the approval of remdesivir (Veklury, Gilead Sciences) to include pediatric patients 28 days of age and older weighing at least 3 kg with positive results of direct SARS-CoV-2 viral testing.
Moderna Requests FDA Authorization of Second Booster for All Adults
Moderna Inc has submitted a request to the US FDA to allow for a second booster (fourth dose) of its COVID-19 vaccine (mRNA-1273) in all US adults.
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FDA Approves First Symbicort Generic to Treat Asthma and COPD
The US FDA approved the first Symbicort generic inhalation aerosol from Mylan Pharmaceuticals for the treatment of asthma and COPD.
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RSV Monoclonal Antibody Nirsevimab Highly Effective in Phase 3 Trial
The investigational long-acting monoclonal antibody Nirsevimab showed 74.5% efficacy against medically attended lower respiratory tract infections caused by RSV in healthy infants.
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More Healthcare Workers Planned to Vaccinate Children Under 5 Compared to Non-HCWs
Fifty-seven percent of parents who are healthcare workers planned to vaccinate their children under age 5 as soon as a vaccine was approved.
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Higher Dose of Ivermectin Tested for Mild-to-Moderate COVID-19
An expanded ACTIV-6 study will test 600 mcg/kg of ivermectin daily for six days in patients who have had a positive COVID-19 test within the past 10 days, and have at least two symptoms of the illness for no more than seven days.
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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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Antiviral Nasal Spray Being Developed by ENA Respiratory, COPD Foundation
ENA Respiratory and the COPD Foundation are partnering to develop an antiviral nasal spray to prevent and reduce incidence and severity of respiratory viral infections in people with chronic lung diseases like COPD.
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GSK and Medicago’s Plant-based Covifenz Vaccine Approved in Canada
Health Canada has approved GlaxoSmithKline and Medicago’s Covifenz COVID-19 vaccine, a plant-based virus-like particles, recombinant, adjuvanted vaccine, for adults age 18-64.
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Boehringer Pulmonary Fibrosis Drug Gets FDA Breakthrough Status
Boehringer Ingelheim’s BI 1015550 is a PDE4B inhibitor with the potential to address both pulmonary fibrosis and inflammation associated with progressive fibrosing interstitial lung diseases.
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Sanofi-GSK Vaccine 100% Effective in Preventing Against Severe COVID-19, Hospitalizations
Sanofi and GSK will submit data from both their booster and Phase 3 efficacy trials to the FDA and other international regulatory agencies for authorization of their Sanofi-GSK COVID-19 vaccine.
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Switching to Dry Powder Inhaler Cuts Carbon Footprint of Asthma Medication Delivery
Researchers say the hydrofluorocarbons in pressurized metered dose inhalers are potent greenhouse gases and switching to dry powder inhalers would cut emissions while not worsening asthma management.
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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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