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BioWorld - Friday, January 30, 2026
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Home » Biomarin aces final exam: Palynziq gains full FDA approval to treat PKU in adults
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Biomarin aces final exam: Palynziq gains full FDA approval to treat PKU in adults

May 29, 2018
By Marie Powers
Biomarin Pharmaceutical Inc. plans to launch Palynziq (pegvaliase-pqpz, previously Peg-Pal and BMN-165), granted full approval by the FDA late Thursday to treat adults with phenylketonuria (PKU), in late June. The San Rafael, Calif.-based company will take what Jeff Ajer, executive vice president and chief commercial officer, described on the company's conference call as a "deliberate and measured approach to titrating patients starting Palynziq to ensure that they remain on therapy and reach their effective maintenance dose."
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