Janssen’s Single-Shot COVID-19 Vaccine Gets Emergency Use Authorization
The EUA was based on data from the randomized, double-blind, placebo-controlled ENSEMBLE trial.
The EUA was based on data from the randomized, double-blind, placebo-controlled ENSEMBLE trial.
The sNDA includes data from a phase 2 trial that evaluated the efficacy and safety of pirfenidone in patients with progressive fibrosing UILD.
Chemotherapy agents such as vincristine sulfate injection, vinblastine sulfate injection, and vinorelbine tartrate injection should only be prepared in IV infusion bags.
The recommendation was made based on the number of confirmed COVID-19 cases among these 2 groups, as well as ethical and scientific considerations.
This is the first time the Agency has authorized a COVID-19 diagnostic test that provides rapid results at home.
The placebo-controlled COVE study is investigating the efficacy and safety of mRNA-1273 at the 100mcg dose (given intramuscularly in a 2-dose series, approximately 28 days apart) in more than 30,000 adults aged 18 years and older.
In a statement, the Company noted that the actions being taken are considered “routine” when an unexplained illness is reported in a clinical trial.
Using a blood sample, the test is able to analyze more than 300 cancer-associated genes for alterations.
The trial, which is the first to be implemented under Operation Warp Speed, is expected to enroll around 30,000 adults and will be conducted at multiple clinical research sites across the US.
The FDA has approved Zepzelca™ (lurbinectedin; Jazz Pharmaceuticals) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.