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The FDA’s independent advisors found Pfizer’s data lacked the precision needed to establish the efficacy of Talzenna in ...
In a somber end to an FDA advisory committee’s two-day scouring of multiple drugmakers’ oncology data, Pfizer’s pitch to ...
Talzenna is currently approved in combination with Xtandi (enzalutamide) for individuals with castration-resistant prostate ...
An eight-member panel voted unanimously against wider use of Pfizer’s Talzenna in advanced prostate cancer. Elsewhere, U.K.
Astellas and Pfizer's Xtandi plus ADT showed a decrease in mortality risk in a metastatic hormone-sensitive prostate cancer ...
Pfizer Inc. failed to convince advisers to the US Food and Drug Administration to support a dramatic expansion in the use of ...
For J&J, there was a positive outcome as the Oncologic Drugs Advisory Committee (ODAC) voted six to two in favour of approval ...
An FDA advisory committee on Wednesday unanimously voted against recommending approval of the PARP inhibitor talazoparib ...