Regulatory News FDA grants Replimune’s RP1 an accelerated approval on third submission after 10:3 vote from advisory committeeAmid political outcry, advisors accept weak data and give sponsor a chance to complete phase III trial August 07, 2026Vol.52 No.31By Jacquelyn Cobb and Paul Goldberg
Podcast Pour a Scotch, we’re talking clinical trials and prediction markets August 05, 2026Vol.52 No.31
Cancer Policy FDA’s OCE publishes three final guidances to increase clinical trial enrollment July 31, 2026Vol.52 No.30By Jacquelyn Cobb
Drugs & Targets After two CRLs, FDA advisory committee votes in favor of Replimune’s melanoma drug July 31, 2026Vol.52 No.30
Podcast Hegseth offers soldiers testosterone and FDA loosens safety warnings. Is the science there? July 29, 2026Vol.52 No.29
Regulatory News Hegseth orders testosterone testing for troops as FDA moves to loosen TRT prostate cancer warningsExperts caution the move amounts to a “huge, unregulated, natural experiment” July 24, 2026Vol.52 No.29By Claire Marie Porter
Drugs & Targets FDA approves Jideytro for previously treated ROS1-positive non-small cell lung cancer July 24, 2026Vol.52 No.29
Drugs & Targets FDA grants priority review for Talzenna + Xtandi combo in earlier prostate cancer July 24, 2026Vol.52 No.29
