Kedrion submits to FDA for Manufacture of RhoGAM/MICRhoGAM in Melville, NY
On Sep 30, 2019 Kedrion Biopharma Inc. (Kedrion Biopharma) met another milestone towards transferring the drug manufacture of RhoGAM/MICRhoGAM from Ortho Clinical Diagnostics (OCD), Raritan, NJ to Kedrion Biopharma’s Melville, NY facility. A robust Prior Approval Supplement (PAS) package was submitted and acknowledged by the FDA for review. The Prescription Drug User Fee Act (PDUFA)
Kedrion Biopharma Announces Completion of Enrollment for CARES10
A Phase 3, Multi-Center Study to Assess a 10% Ig in Adults with Primary Immunodeficiency Disease
First Annual International Symposium for the Global Eradication of Rh Disease ends a year of celebrations
The event, supported by Kedrion among others, was held on November 1st at Columbia University in NY
Kedrion joins Rhesus Solution Initiative (RSI) symposium in Lagos
Nigeria to advocate for Rh Disease universal eradication
Kedrion Biopharma runner up at the Premio Equita for the bond issued in July 2017
The prize is awarded to the companies that made the best use of the capital markets
Hemophilia: Kedrion signs on to groundbreaking PARTNERS programme
Goal is to improve access to replacement therapies for coagulation disorders in Europe
Kedrion and Cerus enter distribution agreement for INTERCEPT in Italy
Agreement covers complete INTERCEPT product line: platelets, plasma and red blood cells
Kedrion Biopharma and Kamada Ltd Receive FDA Approval for KEDRAB®
The product is approved for post-exposure prophylaxis against rabies infection
Kedrion Biopharma signs agreement with European Hemophilia Consortium (EHC)
The agreement aims to improve patient access to coagulation disorders treatments in Europe
New company AO Kirov Plasma established in Russia
It’s a joint venture between Kedrion Biopharma, Nacimbio and Pharmastandard