Ultomiris Approved for Pediatric Patients With Paroxysmal Nocturnal Hemoglobinuria
The approval was based on data from an open-label, phase 3 study that assessed Ultomiris in 13 patients 9 through 17 years of age with PNH.
Diagnosis & Disease Information
Endari Label Updated With Benefit Statement, Instructions for Use
Endari (L-glutamine; Emmaus Medical) is an amino acid indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients aged 5 years and older.
Nipocalimab Gets Fast-Tracked for Hemolytic Disease of the Fetus and Newborn
The Food and Drug Administration (FDA) has granted Fast Track designation to nipocalimab (M281) for the prevention of hemolytic disease of the fetus and newborn (HDFN).
FDA Rejects Edsivo NDA for Vascular Ehlers-Danlos Syndrome
In the CRL, the FDA stated that the Company will need to conduct an adequate and well-controlled trial to evaluate the efficacy of Edsivo in patients with vEDS.
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