Category: Products & Treatment

Products & Treatment

FDA Approves Pfizer’s RSV Vaccine

The FDA approved Abrysvo for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in individuals 60 years and older.

Products & Treatment

Digital Biomarker Predicts Risk of Death in Interstitial Lung Diseases

The tool, which has been granted FDA Breakthrough Device Designation, is being developed to serve as adjunct in assessment of ILD, potentially avoiding expensive, invasive surgical testing.

Products & Treatment

FDA Approves First RSV Vaccine

In clinical trials, the vaccine significantly reduced the risk of developing RSV-associated lower respiratory tract disease by 82.6% and reduced the risk of developing severe RSV-associated lower respiratory tract disease by 94.1% in adults age 60 and older.

Industry & Regulatory News

FDA Blocks 6,500 Flavored E-cigarette Products from 10 Companies

The companies' premarket tobacco product applications, which were for a variety of flavored e-cigarette products, did not provide sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health, according to the FDA.

Pharmaceuticals

FDA Grants Kalydeco Expanded Approval for Infants with Cystic Fibrosis

The medication now is approved for use in children with cystic fibrosis ages 1 month to less than 4 months old who have at least one mutation in their cystic fibrosis transmembrane conductance regulator gene.

Diagnostics & Testing

FDA Grants De Novo Requests for Prescription COVID-19 Antibody Tests

These are the first marketing authorizations for COVID-19 antibody tests using a traditional premarket review process, according to the FDA.

Monitoring & Treatment

Long-forgotten Antibiotic Effective Against Multidrug-resistant Bacteria

The discovery of nourseothricin in the 1940s generated high hopes for it as a powerful agent against Gram-negative bacteria, but its development was dropped after proving toxic to kidneys. However, researchers are now taking another look.