1336 ET - The FDA's new single-trial approval policy could expand pharmaceutical development pipelines, J.P. Morgan analysts say in a research note. In February, the FDA Commissioner unveiled a new default position that just one "adequate and well-controlled" study combined with confirmatory evidence will underpin marketing authorization of novel products. While the practice of conducting one, rather than two, pivotal trials is not a new phenomenon, the analysts say the formal implementation of the policy could drive pharmaceutical companies to reinvest savings from fewer Phase 3 trials into discovery and preclinical programs. Long term, this shift could gradually boost the total number of drugs reaching commercialization, the analysts say.(amira.mckee@wsj.com)

(END) Dow Jones Newswires

March 09, 2026 13:36 ET (17:36 GMT)

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