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Regulatory Specialist ? We provide high-quality regulatory affairs consulting that is tailored to Sponsors' individual needs, and designed to get therapeutics to market as quickly as possible.

FDA approves drug to prevent or reduce the frequency of bleeding episodes for patients with hemophilia A with inhibitors or hemophilia B with inhibitors "The development of inhibitors remains the most serious treatment-related complication for people living with hemophilia. For patients with inhibitors, especially in hemophilia B, their hemophilia may remain poorly controlled and pose a life-threatening risk," said Shapiro, MD, CEO and co-medical director at the Hemophilia & Thrombosis Center, Inc. "The approval of Alhemo??– a first-of-its-kind, prophylaxis, subcutaneous injection pen for adults and children 12 years and older with hemophilia A and B with inhibitors – provides a much-needed alternative to the current standard of care in hemophilia B with inhibitors, while offering patients with hemophilia A with inhibitors more treatment options, ultimately providing more patients with inhibitors the opportunity to personalize their care and address current treatment gaps."

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