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Takeda Receives FDA 510(k) Clearance for HyHubTM and HyHubTM Duo Devices to Simplify HYQVIA® Administration

1. FDA granted 510(k) clearance for HyHubTM and HyHubTM Duo devices. 2. Devices enable needle-free transfer of HYQVIA® for patients 17 and older.

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FAQ

Why Bullish?

The clearance enhances product accessibility and market potential, similar to EpiPen's impact.

How important is it?

FDA approval significantly impacts market credibility and growth prospects, strengthening TAK's position.

Why Long Term?

Regulatory approval can lead to increased adoption and sales over time.

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OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for HyHubTM and HyHubTM Duo, devices for patients 17 years of age and older that allow HYQVIA® [Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase] to be transferred from vials without using a needle in a home environment or clinical setting.2 The HYQVIA administration process consists of dual vial unit.

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