đ° Full Story
U.S. Food and Drug Administration Commissioner Marty Makary defended the agencyâs decision this week to deny approval of Replimuneâs melanoma therapy, reiterating that the company relied on a singleâarm study and failed to provide the wellâcontrolled trial the FDA requested.
In a CNBC interview aired May 5, Makary pointed to the agencyâs publicly released Complete Response Letter as the basis for the rejection and said review teams consistently recommended denial unless substantial evidence from a control group was supplied.
Reuters reported Replimune shares fell about 10% on the news.
The denial follows an earlier rejection in July 2025 and has intensified scrutiny of Makaryâs leadership amid critical media coverage, industry pushback and reported internal agency tensions.
Makary said the FDA has âfollowed the scienceâ and rejected suggestions of impropriety.
Media and market attention, plus reporting that Makary faces internal pressure and White House interest in his performance, have amplified debate over evidentiary standards for oncology approvals and broader regulatory policy under his tenure.
đ Based On
đ°ď¸ The Story So Far: An Evolving Timeline
Wednesday, May 6, 2026 12:31 UTC
FDA chief defends rejection of Replimune melanoma drug
Friday, May 1, 2026 15:31 UTC
FDA advisers reject AstraZeneca breast cancer drug


)



đŹ Commentary