Robert Califf, FDA commissioner (Sipa via AP Images)

The ac­cel­er­at­ed ap­proval path­way is evolv­ing in plain sight, with or with­out con­gres­sion­al help

FDA lead­ers have made clear that re­form­ing the ac­cel­er­at­ed ap­proval path­way is a pri­or­i­ty, and with sev­er­al re­cent ac­tions, the agency has sig­naled that it’s will­ing to take ac­tion on those re­forms even with­out im­me­di­ate move­ment from Con­gress.

The lat­est sign of this evo­lu­tion oc­curred to­day, as GSK an­nounced it was pulling its fifth-line mul­ti­ple myelo­ma drug Blenrep at the FDA’s re­quest — just 15 days post-con­fir­ma­to­ry tri­al fail an­nounce­ment.

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