FDA says COVID-19 vaccine must be effective in half of recipients 01-Jul-2020 By Ben Hargreaves US FDA demands that vaccine must prevent or decrease severity in at least 50% of people receiving doses.
FDA looks to accelerate plasma therapies for coronavirus 06-Apr-2020 By Ben Hargreaves US FDA looks to coordinate and speed up the development of blood-derived therapies to treat patients with COVID-19.
FDA answer to low biosimilar uptake? Increased communication 30-Sep-2019 By Ben Hargreaves US FDA provides information to patients on biosimilars, emphasizing that the treatments provide the same benefits and are as safe as originator products.
Bavarian Nordic receives first-ever monkeypox vaccine approval 26-Sep-2019 By Ben Hargreaves US FDA grants first approval for a monkeypox vaccine and hands Bavarian Nordic a priority review voucher at the same time.