Phenylketonuria
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Sign up freeTop drugs studied for this disease
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FDA approval · 2026-02-27FDA Approved: PALYNZIQ — Supplemental Application (BioMarin Pharmaceutical Inc.)
The FDA approved BioMarin's supplemental application for PALYNZIQ (pegvaliase-pqpz), related to its regulatory action for phenylketonuria.
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EMA approval · 2026-02-11EMA Authorised: Sephience (sepiapterin) — PTC Therapeutics International Limited
The EMA authorised Sephience (sepiapterin) for phenylketonuria, with orphan medicine status, and PTC Therapeutics International Limited as t…
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EMA approval · 2026-02-03EMA Authorised: Sapropterin Dipharma (sapropterin dihydrochloride) — Dipharma Arzneimittel GmbH
The EMA authorised Sapropterin Dipharma (sapropterin dihydrochloride) for phenylketonuria, with Dipharma Arzneimittel GmbH as the marketing …
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FDA approval · 2026-01-08FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Original Application (Micro Labs Limited)
FDA approves an original-application Abbreviated New Drug Application for sapropterin dihydrochloride by Micro Labs Limited. This approval m…
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EMA approval · 2025-12-02EMA Authorised: Upstaza (Eladocagene exuparvovec) — PTC Therapeutics International Limited
The European Medicines Agency has authorised Upstaza (eladocagene exuparvovec) for the treatment of phenylketonuria, an inborn error of amin…
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FDA approval · 2025-11-20FDA Approved: PALYNZIQ — Supplemental Application (BioMarin Pharmaceutical Inc.)
The FDA approved a supplemental application for Palynziq (pegvaliase-pqpz) from BioMarin Pharmaceutical.
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FDA approval · 2025-09-03FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Original Application (TRUPHARMA, LLC)
FDA approved the original application for sapropterin dihydrochloride from Trupharma, LLC, for the treatment of phenylketonuria by reducing …
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FDA approval · 2025-06-11FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s sapropterin dihydrochloride via an original application, adding a new approved product for man…
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FDA approval · 2025-06-09FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)
FDA approved an original ANDA for sapropterin dihydrochloride from Aurobindo Pharma Limited.
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FDA approval · 2025-04-29FDA Approved: ZELVYSIA — Original Application (Aucta Pharmaceuticals, Inc.)
The FDA approved Zelvysia (sapropterin dihydrochloride) via an original Abbreviated New Drug Application from Aucta Pharmaceuticals, Inc. fo…
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FDA approval · 2025-04-03FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for Camber Pharmaceuticals' sapropterin dihydrochloride, establishing a generic version of the treat…
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FDA approval · 2025-02-28FDA Approved: JAVYGTOR — Supplemental Application (Dr. Reddys Laboratories Inc)
FDA approved a supplemental application for JAVYGTOR (sapropterin dihydrochloride) from Dr. Reddys Laboratories Inc.
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FDA approval · 2025-01-24FDA Approved: JAVYGTOR — Supplemental Application (Dr. Reddys Laboratories Inc)
FDA approved a supplemental application for JAVYGTOR (sapropterin dihydrochloride) submitted by Dr. Reddys Laboratories Inc.
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FDA approval · 2025-01-24FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved a supplemental application for sapropterin dihydrochloride from Camber Pharmaceuticals, Inc., for its continued marketing a…
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FDA approval · 2024-08-26FDA Approved: KUVAN — Supplemental Application (BioMarin Pharmaceutical Inc.)
The FDA approved a supplemental application for Kuvan (sapropterin dihydrochloride) from BioMarin Pharmaceutical Inc.
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FDA approval · 2024-08-26FDA Approved: KUVAN — Supplemental Application (BioMarin Pharmaceutical Inc.)
FDA approved BioMarin's supplemental application for Kuvan (sapropterin dihydrochloride), updating the product under a supplemental approval…
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EMA approval · 2024-07-12EMA Authorised: Palynziq (pegvaliase) — BioMarin International Limited
The European Medicines Agency authorised Palynziq (pegvaliase) by BioMarin International Limited for phenylketonuria, with orphan medicine d…
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FDA approval · 2024-03-15FDA Approved: JAVYGTOR — Supplemental Application (Dr. Reddys Laboratories Inc)
The FDA approved a supplemental application for JAVYGTOR (sapropterin dihydrochloride) from Dr. Reddys Laboratories Inc.
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FDA approval · 2023-12-09FDA Approved: PALYNZIQ — Supplemental Application (BioMarin Pharmaceutical Inc.)
The FDA approved BioMarin's supplemental Biologics License Application for PALYNZIQ (pegvaliase-pqpz). The approval covers an additional sub…
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FDA approval · 2022-09-26FDA Approved: JAVYGTOR — Supplemental Application (Dr. Reddys Laboratories Inc)
The FDA approved a supplemental application for JAVYGTOR (sapropterin dihydrochloride) submitted by Dr. Reddys Laboratories Inc.
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FDA approval · 2022-08-23FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved an original application for sapropterin dihydrochloride from Camber Pharmaceuticals, a generic version of the product. The drug…
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FDA approval · 2022-08-18FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' original application for sapropterin dihydrochloride, a generic version of the PKU therapy. This action…
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FDA approval · 2022-05-26FDA Approved: JAVYGTOR — Supplemental Application (Dr. Reddys Laboratories Inc)
FDA approved a supplemental application for JAVYGTOR (sapropterin dihydrochloride) from Dr. Reddys Laboratories Inc.
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FDA approval · 2022-05-17FDA Approved: JAVYGTOR — Supplemental Application (Dr. Reddys Laboratories Inc)
FDA approved a supplemental application for JAVYGTOR (sapropterin dihydrochloride) from Dr. Reddy's Laboratories, updating/expanding its lab…
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FDA approval · 2022-05-13FDA Approved: JAVYGTOR — Original Application (Dr. Reddys Laboratories Inc)
FDA approved the original application (ANDA) for JAVYGTOR, a generic sapropterin dihydrochloride, from Dr. Reddys Laboratories Inc.; it is i…