Medivation/Astellas’ Xtandi was approved barely a month after FDA announced it had accepted its NDA for post-chemo castration-resistant metastatic prostate cancer, and the newly approved androgen blocker appears to have what it takes to unseat J&J’s market leader Zytiga.
Medivation Inc./Astellas Pharma Inc. may face slower uptake for their prostate cancer drug Xtandi (enzalutamide) than Johnson & Johnson did for Zytiga (abiraterone) because of abiraterone’s foothold, but Xtandi has the potential to overtake the prostate cancer market leader.
FDA’s announcement Aug. 31 that it had approved Xtandi (MDV3100) for treatment of metastatic castration-resistant prostate cancer in men who...
The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.
The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.
Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.
