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Merck's experimental ovarian cancer drug gets FDA breakthrough status due to promising early results.
Merck has received FDA Breakthrough Therapy Designation for an experimental drug targeting advanced or recurrent ovarian cancer, based on early data showing strong anti-tumor effects and a good safety profile.
The designation aims to speed up development and review, offering more frequent FDA interactions and potential for accelerated approval.
The drug works by blocking specific pathways involved in cancer progression.
Merck plans to advance the therapy through later-stage trials, seeking to address unmet needs in gynecologic oncology.
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El fármaco experimental contra el cáncer de ovario de Merck obtiene el estatus de avance de la FDA debido a los primeros resultados prometedores.