Drug Approval | May 14, 2026
Pfizer scores landmark EU approval for hemophilia drug HYMPAVZI
The decision marks a significant expansion for Pfizer’s once-weekly injectable therapy
The decision marks a significant expansion for Pfizer’s once-weekly injectable therapy
HYMPAVZI’s approval is based on Phase 3 study results demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors
A one-time dose of DURVEQTIX has reduced bleeds post-treatment compared to standard of care with a median annualized bleed rate (ABR) of zero bleeds (range 0 to 9.9)
PREVENAR offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine to help protect infants and children from the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU and globally
VELSIPITY is the first and only oral advanced ulcerative colitis therapy approved for use in patients 16 years of age or older in the EU
Announces changes in the commercial organization to incorporate Seagen and improve focus, speed and execution
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