Pfizer Inc. failed to convince advisers to the US Food and Drug Administration to support a dramatic expansion in the use of its prostate cancer drug, a setback ... approval of Talzenna, a pill ...

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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 ...

The FDA’s independent advisors found Pfizer’s data lacked the precision needed to establish the efficacy of Talzenna in ...

An FDA advisory committee on Wednesday unanimously voted against recommending approval of the PARP inhibitor talazoparib ...

However, its potential is seen as being tied to the ability of the drug to target the broader population of ESR1 'wild-type' patients While Pfizer trumpeted the result as a "clinically meaningful ...

Talzenna is currently approved in combination ... prostate cancer that have the HRR gene mutation. Pfizer submitted an sNDA to have the drug used with Xtandi but regardless of genetic mutation.

An eight-member panel voted unanimously against wider use of Pfizer’s Talzenna in advanced prostate cancer. Elsewhere, U.K.