The FDA announced on February 18, 2026, that it will no longer require two pivotal clinical trials for new drug approvals, establishing a single-trial approach as the default standard. In a New England Journal of Medicine perspective, FDA leaders argued that the “two-trial dogma”, unchallenged since the 1960s, is obsolete given advances in biology, statistical […]
The European Commission has granted marketing authorization to darolutamide (Nubeqa) combined with androgen deprivation therapy (ADT) for treating metastatic hormone-sensitive prostate cancer (mHSPC). This approval, following a positive opinion from the European Medicines Agency in June 2025, allows darolutamide plus ADT to be used with or without docetaxel, offering clinicians greater flexibility in tailoring treatment. […]
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