25 February 2021 - Submission for entering the world’s largest US marketplace. ...
24 February 2021 - Submission is eligible for priority review and accelerated approval. ...
18 February 2021 - Efanesoctocog alfa, previously known as BIVV001, is an investigational factor VIII replacement therapy that has the potential ...
12 February 2021 - The first and only FDA approved intravenous immunoglobulin with two maintenance dosing options for chronic inflammatory ...
2 December 2020 - Catalyst Biosciences today announced the U.S. FDA has granted fast track designation for marzeptacog alfa (activated) – ...
9 November 2020 - PDUFA date extended by FDA from 5 March 2021 to 5 June 2021. ...
28 October 2020 - Initial agreement for 300,000 vials with potential for purchase of an additional 650,000 vials. ...
20 October 2020 - All the weak points of American health care — testing delays, communication breakdowns, inequity — are working ...
19 October 2020 - Octapharma is pleased to announce that the U.S. FDA has approved an updated Prescribing Information for Nuwiq, ...
7 October 2020 - The company said that doses of the unproven treatment would be available for 50,000 patients. It’s impossible ...
28 September 2020 - Haegarda is the first and only subcutaneous prophylactic hereditary angioedema treatment approved for children 6 years of ...
21 September 2020 - FDA assigns PDUFA target action date of 5 March 2021. ...
8 September 2020 - Results from pivotal Phase 2/3 study met co-primary endpoints for improvement in trough plasminogen activity levels and ...
29 August 2020 - Emily Miller joined the agency as chief spokeswoman this month. ...
26 August 2020 - Food and Drug Administration Commissioner Stephen Hahn is apologising for overstating the life-saving benefits of using convalescent ...