Press Releases

FDA No Longer Plans to Hold an Advisory Committee Meeting, as Previously Planned, to Discuss the Biologics License Application (BLA) BioMarin Remains on Track to Host Scheduled Manufacturing...

FDA Pre-Licensure Inspection of Gene Therapy Manufacturing Facility Scheduled FDA Requests Submission of Upcoming 3-Year Data Analysis from Phase 3 GENEr8-1 Study Current PDUFA Target Action Date...

Credit Suisse 31st Annual Healthcare Conference 2022: November 8th, 8:35amPT/11:35amET, in Rancho Palos Verdes, CA 13th Annual Jefferies Global Healthcare Conference 2022: November 16th, 8:35amGMT, in

VOXZOGO® $48 Million Contribution in the Quarter Results in BioMarin Raising Full-year 2022 VOXZOGO Net Product Revenue Guidance to Between $140 Million and $170 Million U.S. Biologics...

If Approved, Would Be 1st Gene Therapy in U.S. for Treatment of Severe Hemophilia A PDUFA Target Action Date is March 31, 2023 SAN RAFAEL, Calif., Oct. 12, 2022 /PRNewswire/ -- BioMarin...

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced its decision to redesign the organization to better focus investments that advance its R&D pipeline, maximize recent commercial launch...

BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin, will host a conference call and webcast on Wednesday,...

BLA Includes Substantial Body of Data from Pivotal Phase 3 and Ongoing Phase 1/2 Studies If Approved, Would Be 1st Gene Therapy in U.S. for Treatment of Severe Hemophilia A SAN RAFAEL, Calif.,...

Institute for Clinical and Economic Review (ICER) Base-Case Model Report Results in $4 Million Savings Versus Emicizumab Prophylaxis Per Patient Over a Lifetime Biologics License Application (BLA)...

Maintains Orphan Drug Designation (ODD) in the EU Providing 10-years of Market Exclusivity Significant Benefit Over Existing Therapies for Patients with Severe Hemophilia A in EU Based on EMA...