SAN RAFAEL, Calif., Aug. 19, 2015 (GLOBE NEWSWIRE) — BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced that the U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designation for drisapersen, a potential treatment for patients with Duchenne Muscular Dystrophy (DMD) who are amenable to exon 51 skipping treatment. The FDA has previously granted drisapersen… Continue reading BioMarin Receives Rare Pediatric Disease Designation From FDA for Drisapersen for the Potential Treatment of Duchenne Muscular Dystrophy
Category: news
Kiadis Pharma announces it raised an additional € 2.0 million via exercise of the Over-Allotment Option and the end of the stabilisation period in relation to its initial public offering
Amsterdam, the Netherlands, July 31, 2015 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Euronext Brussels: KDS), a recently-listed clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces the partial exercise of the Over-Allotment Option by Kempen & Co N.V. acting on… Continue reading Kiadis Pharma announces it raised an additional € 2.0 million via exercise of the Over-Allotment Option and the end of the stabilisation period in relation to its initial public offering
Kiadis Pharma Announces Full Enrolment of its Phase II Clinical Study with Lead Product, ATIR101™
The target 23 patients have now been enrolled Amsterdam, the Netherlands, July 30, 2015, 7.00 CEST – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Euronext Brussels: KDS), a recently listed clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces full enrolment of… Continue reading Kiadis Pharma Announces Full Enrolment of its Phase II Clinical Study with Lead Product, ATIR101™
BioMarin Announces FDA Accepts Drisapersen NDA for Treatment of Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
FDA Grants Priority Review Status; FDA PDUFA Date is December 27, 2015 SAN RAFAEL, Calif., June 29, 2015 (GLOBE NEWSWIRE) — BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the submission of a New Drug Application (NDA) for drisapersen for the treatment of Duchenne muscular dystrophy… Continue reading BioMarin Announces FDA Accepts Drisapersen NDA for Treatment of Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
BioMarin Announces EMA Validates MAA for Drisapersen for Treatment of Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
SAN RAFAEL, Calif., June 25, 2015 (GLOBE NEWSWIRE) — BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for drisapersen for the treatment of Duchenne Muscular Dystrophy amenable to exon 51 skipping. Validation of the MAA confirms that the submission is complete and starts the EMA’s… Continue reading BioMarin Announces EMA Validates MAA for Drisapersen for Treatment of Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
