Bayer announced the submission of a supplemental new drug application to FDA for the oral androgen receptor inhibitor Nubeqa (darolutamide) in combination with androgen deprivation therapy for the treatment of patients with metastatic hormone-sensitive prostate cancer.
In his first sit-down interview since beginning his role as FDA commissioner 17 days earlier, Marty Makary, a former Johns Hopkins surgeon and the only Trump pick for HHS whose confirmation received Democratic support, said he would speed up approvals for rare-disease treatments by reducing reliance on animal testing and shifting towards organoids and computational models.
