FDA: JUUL E-Cigarette Products Banned in US
Individual consumers are not restricted from having or using JUUL products; however, the Agency will ensure compliance by retailers.
All articles by Steve Duffy
Intranasal RSV Vaccine Fast Tracked for Those Over 60 and Children Under 2
According to the Company, preclinical studies demonstrated that the vaccine induces serum antibody and mucosal antibody responses.
Oral Treatment for COVID-19 Gains Fast Track Designation
EDP-235 is currently being examined in a first-in-human phase 1 trial to assess safety, tolerability, and pharmacokinetics.
E-Cigarette Smoking History Tied to Increased Bladder, Lung Cancer Risk
Findings demonstrated that all smoking histories were tied to a higher prevalence of bladder and lung cancer.
FDA Grants First Full Approval to Pfizer-BioNTech COVID-19 Vaccine
The approval is indicated for individuals 16 years of age and older, however the vaccine remains available to those aged 12 years and older under the EUA.
Results Announced in Phase 3 Trial of Ruxolitinib in COVID-19 Associated ARDS
Patients were randomized to receive either ruxolitinib 5mg twice daily (BID) plus standard of care (SoC), ruxolitinib 15mg BID plus SoC or placebo plus SoC.
Tocilizumab Gains New Indication for Systemic Sclerosis-Associated Interstitial Lung Disease
The FDA has approved Actemra® (tocilizumab; Genentech) subcutaneous injection for slowing the rate of decline in pulmonary function in SSc-ILD.
First OTC Molecular COVID-19 Test Receives EUA for At-Home Use
The test correctly identified 96% of positive samples from individuals known to have symptoms and 100% of positive samples from individuals without symptoms.
Novel Device for Sleep Apnea, Snoring Receives FDA Approval
The eXciteOSA device is used while the individual is awake and provides electrical muscle stimulation through a mouthpiece that sits around the tongue.
NIH: Study Will Identify Most Promising Therapies for COVID-19
So far, the therapies scheduled to be part of the trial are risankizumab, an interleukin-23 antagonist, and lenzilumab, an anti-human granulocyte macrophage-colony stimulating factor monoclonal antibody.
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