News from HFA
- BioMarin Update: FDA Extends PDUFA Target Action Date to June 30, 2023
SAN RAFAEL, Calif., March 6, 2023 — BioMarin Pharmaceutical Inc., a global biotechnology company dedicated to transforming lives through genetic discovery, announced that it received notice this afternoon from the U.S. Food and Drug Administration (FDA) that the agency has extended review of the company’s Biologics License Application (BLA) for ROCTAVIAN™ (valoctocogene roxaparvovec) gene therapy for adults The post BioMarin Update: FDA Extends PDUFA Target Action Date to June 30, 2023 appeared first on Hemophilia Federation of America.
- The Complexity of Unwinding Medicaid
The long-heralded Medicaid “unwinding” has begun. As previously reported, state Medicaid programs have, since the start of the COVID-19 pandemic, operated under a law that prohibited them from disenrolling Medicaid enrollees for the duration of the public health emergency (PHE). Congress changed that requirement in December 2022, delinking the Medicaid continuous enrollment obligation from the PHE. The post The Complexity of Unwinding Medicaid appeared first on Hemophilia Federation of America.
- FDA Approves Sanofi’s Once-Weekly ALTUVIIIO™
Source: Sanofi Press Release Sanofi announces that the U.S. Food and Drug Administration approved ALTUVIIIO™ [Antihemophilic Factor (Recombinant), Fc-vWF-XTEN Fusion Protein-ehtl], previously known as efanesoctocog alfa, a first-in-class, high-sustained factor VIII replacement therapy for adults and children with hemophilia A. Sanofi states that with ALTUVIIIO, they are looking to raise the bar for people with The post FDA Approves Sanofi’s Once-Weekly ALTUVIIIO™ appeared first on Hemophilia Federation of America.
- Dear Addy: Project CALLS
Dear Addy, I recently attended an event and learned about submitting issues with my insurance to HFA’s Project CALLS. I have an insurance issue, however, I still have some questions about how CALLS works and what happens when I submit an issue. Can you explain the process? Signed, CALLS Quandary Dear Quandary, You are not The post Dear Addy: Project CALLS appeared first on Hemophilia Federation of America.
- Finding Strength Through Diversity
This Black History Month, HFA asks our community to think back on the family members they’ve loved and the moments they created. We ask our community to think on the diversity of our community, the stories we’ve shared, and the people of color who helped make the bleeding disorder community as strong as it is The post Finding Strength Through Diversity appeared first on Hemophilia Federation of America.