First therapy for paroxysmal nocturnal hemoglobinemia given FDA nod
The FDA has given the green light to eculizumab (Soliris) from Alexion Pharmaceuticals as the first treatment for patients with paroxysmal nocturnal hemoglobinemia (PNH) to reduce hemolysis.
The FDA has given the green light to eculizumab (Soliris) from Alexion Pharmaceuticals as the first treatment for patients with paroxysmal nocturnal hemoglobinemia (PNH) to reduce hemolysis. PNH is a rare, life-threatening disorder defined by chronic red blood cell destruction that often strikes people in their early 30s, with an average survival time of 10 to 15 years from time of diagnosis. Alexion has also announced the launch of Soliris One Source, a treatment support service that will provide PNH patients education about the new product.
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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.
