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Merck Says FDA Approves Update To US Product Label For WINREVAIR For Injection, 45mg, 60mg, Based On The Phase 3 HYPERION Trial

Sep 22, 2026 · 06:48 AM ET· updated 2h ago

In HYPERION, in patients diagnosed with PAH in the last 12 months, adding WINREVAIR on top of background therapy reduced the risk of clinical worsening events compared to placebo, informing the use of WINREVAIR earlier

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Why It Matters

The FDA approved a label update for Merck's WINREVAIR medicine. The update shows the drug helps newer PAH patients when added to other treatments.

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Source: Benzinga · Read the original report at the publisher. Headline and figures shown for context; data may be delayed.

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