3rd Generation Tankless Inhaled Nitric Oxide System Gets FDA Approval
The US FDA has approved the third Generation Genosyl Delivery System, a tankless inhaled nitric oxide (iNO) therapy device, according to manufacturer Vero Biotech Inc.
Category: US Pharmaceuticals
US Pharmaceuticals
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US Pharmaceuticals
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Moderna Submits Omicron-targeting Bivalent Booster Vaccine to FDA
Moderna Inc has completed its submission to the FDA for emergency use authorization for its BA.4/BA.5 Omicron-targeting bivalent booster vaccine, mRNA-1273.222.
US Pharmaceuticals
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New Class of Antibiotics Effective Against Drug-resistant Tuberculosis
A new class of antibiotics is highly effective against drug-resistant tuberculosis and, if validated, would represent a major advance in the treatment of TB.
FDA Approves Olumiant for Hospitalized COVID Patients
The FDA approved Olumiant (baricitinib) for hospitalized adults with COVID-19 requiring supplemental oxygen, noninvasive or invasive mechanical ventilation, or ECMO.
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Research to Focus on Use of Azithromycin for Wheeze, Asthma in Preschoolers
Researchers at the University of Arizona Health Sciences are using a $6.7 million National Institutes of Health grant to study azithromycin therapy in preschoolers who are diagnosed with severe wheezing episodes at hospital emergency departments.
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FDA Limits Use of J&J Janssen COVID-19 Vaccine
The FDA limited authorized use of the J&J Janssen COVID-19 vaccine to certain individuals due to risk of thrombosis with thrombocytopenia syndrome.
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NIH to Evaluate Second COVID Booster in Adults
A Phase 2 clinical trial to evaluate second COVID booster shots has begun enrolling adult participants in the United States. The COVID-19 Variant Immunologic Landscape (COVAIL) trial, sponsored by the NIAID, aims to understand if different vaccine regimens—prototype and variant vaccines alone and in combinations—can broaden immune responses in adults who already have received a primary vaccination series and a first booster shot.
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Pfizer Submits Pediatric COVID Booster for Authorization
Pfizer Inc and BioNTech SE have submitted an application for US FDA authorization of a 10-µg booster dose of its pediatric COVID booster for children age 5 through 11 years old.
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Moderna Developing Bivalent COVID Vaccine Booster
Moderna’s first bivalent COVID vaccine booster candidate, mRNA-1273.211, demonstrated superior neutralizing titers compared to mRNA-1273 against all variants of concern, including Omicron.
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Clinical Trial Will Study Allergic Reactions to COVID Vaccines
A clinical trial by the NIAID will study rare but potentially serious systemic allergic reactions to COVID vaccines.
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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.
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COVID Nasal Spray May Inhibit Infection
Researchers are developing a COVID nasal spray to inhibit SARS-CoV-2 infection. The newly discovered small molecule N-0385 could be sprayed into people’s noses to prevent COVID-19 illness.
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Positive Data for Pfizer Pediatric Booster
A 10-µg dose (third dose) of the Pfizer pediatric booster in healthy children age 5 through 11...
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Study Evaluates Inhaled Nitric Oxide for COVID-19
Researchers assessed outcomes of INOmax inhaled nitric oxide for COVID-19 patients hospitalized with mild-to-moderate ARDS.
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CoVac-1 COVID Vaccine May Provide Protection for Cancer Patients with B-cell Deficiencies
The novel CoVac-1 COVID vaccine induced T-cell immune responses in 93% of patients with B-cell deficiencies, including many patients with leukemia and lymphoma.
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