Second Booster Dose Authorized to Increase Protection Against COVID-19 for Certain People
The Emergency Use Authorization was based on safety and immunogenicity data provided to the Agency.
The Emergency Use Authorization was based on safety and immunogenicity data provided to the Agency.
The sBLA includes data from the phase 3 OSTRO study, which showed that treatment with subcutaneously administered benralizumab led to statistically significant improvements.
The Agency issued the notification order as it deemed the Company’s notification efforts to be inadequate.
A list of FDA authorized COVID-19 home tests.
Molnupiravir is an orally administered form of a ribonucleoside analogue that inhibits the replication of SARS-CoV-2.
Findings from an ongoing randomized, placebo-controlled, observer-blind phase 3 trial showed Spikevax was 93.2% effective at preventing COVID-19.
Concise drug information for molnupiravir and Paxlovid; the FDA granted Emergency Use to both oral antiviral therapies.
Cases of TTS have been reported in both males and females.
Patients who had more than 5 episodes of croup were more likely to benefit from inhaled corticosteroids.
The study authors identified 32 studies that reported on side effects following e-cigarette use.