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The FDA has expanded the label for Pfizer’s subcutaneous hemop | The FDA has expanded the label for Pfizer’s Hympavzi, now including patients age 6 and older who have hemophilia A or B. The new expansion covers all patients 6 and older, regardless of their inhibitor status. The new nod also opens up the treatment to those 12 and older who have developed inhibitors.
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The FDA has expanded approval for marstacimab-hncq, which can now be given as routine prophylaxis for all individuals aged 6…

Pfizer has received EC approval to expand the Hympavzi indication to treat haemophilia A or B with inhibitors in patients aged 12…

More than three years after Gilead Sciences’ hepatitis D drug bulevirtide was rebuffed by the FDA on manufacturing and delivery…

A combination of Merck’s islatravir and Gilead’s lenacapavir has

After the drug’s local license holder called for a brief pause in new patient starts last week, doctors in Japan can once again…

Welcome to Fierce Pharma's regulatory tracker for the first half of 2026. | In this tracker, Fierce Pharma is recording the…