Insmed Inc. has received the green light from the FDA for iPlex (mecasermin rinfabate [rDNA origin] injection) for the treatment of growth failure in children with severe primary IGF-1 deficiency or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. According to the Richmond, Va., firm, iPlex is the only approved once-daily IGF-1 replacement therapy available to treat children with short stature.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.