News AnalysisRegulatory News FDA advisory committee votes in favor of Galleri approval, but calls for removal of “early” detection claimsClinical benefit will not be considered for approval, FDA says September 25, 2026Vol.52 No.35By Jacquelyn Cobb and Sara Willa Ernst
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
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
Regulatory News FDA final guidance on psychedelics opens the door to psycho-oncology researchGuidance permits treatment without psychotherapy, alarming scientists, advocates July 17, 2026Vol.52 No.28By Sara Willa Ernst
Regulatory News OMB proposal to sideline peer review sparks widespread oppositionNearly 500,000 public comments flood in—here are some highlights July 17, 2026Vol.52 No.28By Claire Marie Porter
Regulatory News To keep the early clinical trial enterprise in the U.S., HHS pledges to simplify regulatory requirements June 26, 2026Vol.52 No.25By Paul Goldberg
Regulatory News Is psilocybin heading to a cancer clinic near you?Reversing Nixon-era taboo, Trump orders FDA to fast-track psychedelics and ARPA-H to fund research June 18, 2026Vol.52 No.24By Sara Willa Ernst
Regulatory News After a year-long reign over tumult at FDA, Makary heads for the exitFruit-flavored e-cigs were the final blow for the commissioner May 15, 2026Vol.52 No.19By Claire Marie Porter
Regulatory News Breakthrough Therapy designation, ASCO plenary, and NEJM publication notwithstanding, breast cancer drug camizestrant gets a No from ODAC May 08, 2026Vol.52 No.18By Jacquelyn Cobb
Regulatory News FDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patients“Patients are owed another review.” May 01, 2026Vol.52 No.17By Sara Willa Ernst
