Pfizer Receives the US FDA Approval for Hympavzi to Treat Hemophilia A or B in Two Populations

Shots: The US FDA has approved Pfizer's Hympavzi for the treatment of pts (≥12yrs.) with hemophilia A or B with inhibitors & in pts (6-11yrs.) with hemophilia A or B with or without inhibitors Approval of Hympavzi (SC, QW) in pts (≥12yrs.) was supported by the P-III (BASIS) trial, showing improved key bleeding outcomes incl.…

ByRidhi Rastogi2 days ago

Pfizer Receives the EC Approval for Hympavzi to Treat Hemophilia A and B

Shots: The EC has approved Pfizer's Hympavzi (marstacimab; QW, SC) for the treatment of pts (≥12yrs., ≥35kg) with hemophilia A with FVIII inhibitors or hemophilia B with FIX inhibitors, based on P-III (BASIS) study During the active treatment period, Hympavzi achieved a 93% reduction in mean treated ABR vs on-demand therapy (1.39 vs 19.78), plus…

ByRidhi RastogiMay 13, 2026

Pfizer Receives the US FDA Priority Review for Hympavzi to Treat Hemophilia A or B in Two Populations

Shots: The US FDA has accepted sBLA & granted priority review to Hympavzi for the treatment of pts (≥6yrs.) with hemophilia A or B with inhibitors & in pts (6-11yrs.) with hemophilia A or B without inhibitors (PDUFA: Q2’26) sBLA for Hympavzi (SC, QW) in adults & adolescents was supported by data from the inhibitor…

ByRidhi RastogiFebruary 9, 2026

Pfizer Receives the US FDA Approval for Hympavzi to Treat Hemophilia A or B in Two Populations

Pfizer Receives the EC Approval for Hympavzi to Treat Hemophilia A and B

Pfizer Receives the US FDA Priority Review for Hympavzi to Treat Hemophilia A or B in Two Populations

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