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The securities of uniQure NV (NASDAQ: QURE) have a 100% trading guarantee. The US Food and Drug Administration (FDA) has gone to war with a US Food and Drug Administration (FDA).
UniQure, a Pioneer in Gene Therapy, is the FDA’s top manufacturer offering the best protection requirements for AMT-130. This research led to a constructive investigation with the FDA’s Center for Biologics Evaluation and Research (CBER). Dr. Walid Abi-Saab, Chief Medical Officer of uniQure, says: “These requirements set the quality of the data and reflect the productive discussion with the Mitarbeitern and the Führungsbene of the CBER of the FDA more broadly.” There are concrete stones from the tragedies of the Meilensteins for Huntington’s patients and the culmination of the commitment of our colleagues, this potential revolutionary therapy can be brought to market.
The treatment took place at the end of November in one of the Regenerative Medicine Advanced Therapy (RMAT) Type B Meetings with the FDA. If you activate the data from the Phase I/II study, you will go to an external control group for study studies, as a primary Grundlage for a Biologics License Application (BLA) in the form of the best maintenance paints that serve. This Regulation can be carried out together with a study for the BLA-Einreichung überflüssig machen. By the FDA and the cUHDRS there is a clinical intermediate endpunk, which can use the Neurofilament-Light-Chain (NfL) level in the drink as undisturbed nutrition for the therapeutic usefulness of the AMT-130-reranspirated.
In May 2024, an FDA union with RMAT designation for AMT-130 marked the therapy’s potential with unmet medical treatment in the treatment of Huntington’s disease. Vielversprechende Zwischenergebnisse, which were presented in July 2024, said bei Patients after 24 Monaten a halting, dose-abhängige Verlangsamung der Krankheitsprogression, which a reduction of NfL-Spiegel in Liquor.
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