The US Food and Drug Administration granted clearances for testing instruments, a blood clot drug companion diagnostic test, and infectious disease tests, among other devices.

Soleo Health has been named the exclusive in-network specialty pharmacy for Qfitlia (fitusiran) by Sanofi, the first ...

Qfitlia (fitusiran) is the first therapy for both hemophilia A or B, with or without inhibitors, available in the United ...

The gene therapy BBM-H901 (dalnacogene ponparvovec) has been approved in China for adults with moderate to severe hemophilia ...

Fitusiran, which will be marketed by the name of Qfitlia, becomes the first therapy approved in the United States for treating hemophilia A or B with or without inhibitors. The approval is based ...

Sanofi's reversible BTK inhibitor rilzabrutinib has gained the US Food and Drug Administration’s (FDA) orphan drug designation.

Dose and frequency should be adjusted based on antithrombin activity, using the Innovance Antithrombin companion diagnostic test. The Food and Drug Administration (FDA) has approved Qfitlia ...

Get Instant Summarized Text (Gist) The FDA has approved Qfitlia (fitusiran) for reducing bleeding episodes in patients aged 12 and older with hemophilia A or B, with or without inhibitors. Qfitlia ...

WEDNESDAY, April 2, 2025 (HealthDay News) — The U.S. Food and Drug Administration has approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in ...

The U.S. Food and Drug Administration has approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of ...

The FDA has approved fitusiran, now named Qfitlia, for routine prophylaxis in patients aged 12 and older with hemophilia A or B, with or without inhibitors. Qfitlia offers less frequent administration ...