Blog
RSS FeedPosted by Michael Wonder on 25 Aug 2020
F.D.A. ‘grossly misrepresented’ blood plasma data, scientists say
24 August 2020 - Many experts — including a scientist who worked on the Mayo Clinic study — were bewildered about ...
Posted by Michael Wonder on 24 Aug 2020
FDA's convalescent plasma EUA requires all donor blood units be tested only with Ortho's COVID-19 IgG antibody test
24 August 2020 - In its August 23 Emergency Use Authorisation for COVID-19 convalescent plasma for the treatment of hospitalised ...
Posted by Michael Wonder on 23 Aug 2020
FDA issues emergency use authorisation for convalescent plasma as potential promising COVID–19 treatment, another achievement in Administration’s fight against pandemic
23 August 2020 - Today, the U.S. FDA issued an emergency use authorisation for investigational convalescent plasma for the treatment ...
Posted by Michael Wonder on 30 Jul 2020
FDA nears decision authorising COVID-19 treatment with convalescent plasma
29 July 2020 - Antibody-rich blood plasma would be one of the first coronavirus treatments to receive approval, which could pave ...
Posted by Michael Wonder on 25 Apr 2020
CSL's blood payments in US under the microscope
25 April 2020 - CSL has been forced to defend the way it runs its blood plasma collection business in ...
Posted by Michael Wonder on 07 Apr 2020
Global plasma leaders collaborate to accelerate development of potential COVID-19 hyperimmune therapy
6 April 2020 - Partnership brings together world-leading plasma companies to focus on developing and delivering a hyperimmune immunoglobulin in the ...
Posted by Michael Wonder on 01 Apr 2020
FDA approves additional treatment for adults and adolescents with haemophilia A or B and inhibitors
1 April 2020 - The U.S. FDA today approved Sevenfact [coagulation factor VIIa (recombinant)-jncw] for the treatment and control of bleeding ...
Posted by Michael Wonder on 05 Nov 2019
A severe shortage hits a drug used for cancer, immune disorders, epilepsy, causing canceled treatments and rationing
5 November 2019 - A severe shortage of immune globulin — a popular medicine used to treat epilepsy, cancer and ...
Posted by Michael Wonder on 08 Oct 2019
FDA approves Octapharma’s Wilate for haemophilia A in adult and adolescent patients
8 October 2019 - Octapharma USA today announced the U.S. FDA has approved Wilate for treatment of adults and adolescents with ...
Posted by Michael Wonder on 08 Jul 2019
ADMA Biologics receives FDA approval for license transfers for Bivigam and Nabi-HB
8 July 2019 - All aspects of the Biotest Therapy Business Unit acquisition are successfully completed. ...
Posted by Michael Wonder on 04 Jul 2019
Grifols announces FDA approval of Xembify, 20% subcutaneous immunoglobulin for primary immunodeficiencies
4 July 2019 - Xembify is Grifols’ first 20% subcutaneous immunoglobulin for the treatment of primary immunodeficiencies. ...
Posted by Michael Wonder on 12 May 2019
FDA approves prior approval supplement for Bivigam
10 May 2019 - ADMA Biologics announces that the U.S. FDA has approved the Company’s prior approval supplement for Bivigam (immune ...
Posted by Michael Wonder on 03 Apr 2019
FDA approves Asceniv, a novel intravenous immune globulin
1 April 2019 - Approved for use in the treatment of primary humoral immunodeficiency disease in adults and adolescents (12 to ...
Posted by Michael Wonder on 20 Feb 2019
Novo Nordisk receives US FDA approval of Esperoct (turoctocog alfa pegol, N8-GP)
19 February 2019 - Novo Nordisk today announced that the US FDA has approved the biologics license application for Esperoct ...
Posted by Michael Wonder on 07 Jan 2019
ADMA Biologics submits response and provides supplemental information to FDA for Bivigam complete response letter
7 January 2019 - ADMA Biologics announces that the Company has submitted responses to the U.S. FDA complete response letter received ...