FDA issues Complete Response Letter for RGX-121 (clemidsogene lanparvovec) for treatment of Mucopolysaccharidosis II (MPS II)REGENXBIO plans to work with FDA on a path forward with the goal of resubmitting the BLA....
REGENXBIO Announces Regulatory Update on RGX-121 BLA for MPS II • FDA issues Complete Response Letter for RGX-121 (clemidsogene lanparvovec) for treatment of Mucopolysaccharidosis II (MPS II).
Bilawal expressed these views while speaking to the media at the inauguration ceremony of the SindhInstitute of Child Health and Neonatology in Larkana...Action will be taken against you in accordance with the law and Constitution” ... ....
Orphan Drug Designation for MPS II builds on Immusoft's clinical progress in MPS I and supports expansion of its engineered B cell platform across multiple indications ... .