Drug Approval | May 15, 2026
Alembic Pharma receives USFDA tentative approval for Darolutamide tablets
Darolutamide Tablets, 300 mg, had an estimated market size of US$ 3,155 million in the United States
Darolutamide Tablets, 300 mg, had an estimated market size of US$ 3,155 million in the United States
The trial met its primary endpoint, with the combination therapy demonstrating a “statistically significant and clinically meaningful” improvement in radiographic progression-free survival
The study hit its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) compared to placebo plus XTANDI
Patients with BRCA mutations often face aggressive disease and poor prognosis
XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy in nonmetastatic castration-sensitive prostate cancer
Study achieves primary endpoint of radiographic progression-free survival
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