The EUA was based on historical evidence indicating some effectiveness with convalescent plasma use in previous outbreaks of respiratory viruses, preclinical data, results from small clinical trials, and data from the National Expanded Access Treatment Protocol sponsored by the Mayo Clinic.
Vaccination with mRNA-1273, Moderna’s coronavirus disease 2019 (COVID-19) vaccine candidate, led to robust immune responses and protection against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in nonhuman primates.
Pfizer and BioNTech have selected a coronavirus disease 2019 (COVID-19) vaccine candidate and have initiated their phase 2/3 safety and efficacy trial.
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.
Acalabrutinib, a Bruton tyrosine kinase (BTK) inhibitor, appears to reduce respiratory distress as well as the hyperinflammatory immune response associated with coronavirus disease 2019.
The FDA has approved a new ready-to-dilute liquid formulation of Akynzeo® injection (fosnetupitant/palonosetron; Helsinn) for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, in combination with dexamethasone in adults.
The FDA has launched a new webpage with information for recovered individuals who were infected with coronavirus disease 2019 (COVID-19) on where they can go to donate plasma to aid in the treatment of severely ill patients.
Convalescent plasma, which is collected from patients who have recovered from COVID-19, contains antibodies to SARS-CoV-2, the virus that causes the disease.
The FDA has approved Reblozyl (luspatercept–aamt; Celgene and Acceleron) for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions.
An investigational gene therapy has been granted Orphan Drug designation from the Food and Drug Administration for the treatment of Gaucher disease.
