Erteilung des Status eines Therapiedurchbruchs für Sanbexin-Sublingualtabletten durch die ...
Simcere Pharmaceuticals' Sanbexin-Sublingualtabletten, an innovative stroke treatment, received Breakthrough Therapy designation from the FDA. This marks the first time the FDA has recognized a breakthrough therapy for stroke treatment. The designation aims to expedite the development and review of drugs for serious conditions, significantly shortening the time for market approval. Clinical trial data showed significant improvements in neurological recovery and self-care ability in AIS patients, published in JAMA Neurology.
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Simcere Pharmaceuticals' Sanbexin-Sublingualtabletten, an innovative stroke treatment, received Breakthrough Therapy designation from the FDA. This marks the first time the FDA has recognized a breakthrough therapy for stroke treatment. The designation aims to expedite the development and review of drugs for serious conditions, significantly shortening the time for market approval. Clinical trial data showed significant improvements in neurological recovery and self-care ability in AIS patients, published in JAMA Neurology.