Marketing Application in Europe Remains Under Review SAN RAFAEL, Calif., Jan. 14, 2016 (GLOBE NEWSWIRE) — BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter to the Company’s New Drug Application (NDA) for KyndrisaTM (drisapersen) for the treatment of Duchenne muscular dystrophy (Duchenne) amenable to… Continue reading FDA Issues Complete Response Letter for KyndrisaTM for Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
Blog posts
Kiadis Pharma announces a global collaboration with the Thalassaemia International Federation
~ ATIR201™ on track to enter Phase I/II clinical development in Q1 2016 ~ Amsterdam, The Netherlands, December 21, 2015 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces a collaboration… Continue reading Kiadis Pharma announces a global collaboration with the Thalassaemia International Federation
BioMarin Announces That FDA Has Advised it Will Not Take Action on the Kyndrisa™ (drisapersen) New Drug Application by the PDUFA Date
SAN RAFAEL, Calif., Dec. 18, 2015 (GLOBE NEWSWIRE) — BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today that the U.S. Food and Drug Administration (FDA) has notified the Company that they had not yet completed their review process and would be unable to take an action by the Prescription Drug User Fee Act (PDUFA) action date for… Continue reading BioMarin Announces That FDA Has Advised it Will Not Take Action on the Kyndrisa™ (drisapersen) New Drug Application by the PDUFA Date
Kiadis Pharma presents an update on its Phase II trial with ATIR101™ at the American Society of Hematology 2015 Annual Meeting
– Statistically significant increase in Overall Survival and reduction in Transplant Related Mortality observed in comparison to a historical control group – Zero patients developed grade III-IV acute Graft-versus-Host-Disease upon infusion of ATIR101™ – Analysis of full read out of primary endpoint data anticipated to be reported in April 2016 Amsterdam, The Netherlands, December 7,… Continue reading Kiadis Pharma presents an update on its Phase II trial with ATIR101™ at the American Society of Hematology 2015 Annual Meeting
Kiadis Pharma Interim Management Statement for the nine months ended 30 September 2015
Amsterdam, The Netherlands, November 27, 2015 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces its Interim Management Statement for the nine months ended 30 September 2015. Operational review Kiadis Pharma… Continue reading Kiadis Pharma Interim Management Statement for the nine months ended 30 September 2015
