美国食品药品监督管理局(FDA)已为施贵宝(Bristol-Myers Squibb)的一项申请设定了目标审评日期——2026年8月17日。与此同时,FDA还授予了该疗法突破性疗法认定以及优先审评资格。这一系列举措显著加速了该疗法的审评进程,体现了监管机构对其潜在临床价值的认可。
美国食品药品监督管理局(FDA)已为施贵宝(Bristol-Myers Squibb)的一项申请设定了目标审评日期——2026年8月17日。与此同时,FDA还授予了该疗法突破性疗法认定以及优先审评资格。这一系列举措显著加速了该疗法的审评进程,体现了监管机构对其潜在临床价值的认可。
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