FDA's Single Pivotal Trial Policy Seen Driving Drug Pipelines -- Market Talk

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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)

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

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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. 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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) \n</p>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  March 09, 2026 13:36 ET (17:36 GMT)\n</p>\n<p>\n  Copyright (c) 2026 Dow Jones &amp; Company, Inc.\n</p>\n</font>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4588","symbol_name":"碎股","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2618675146","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2618675146","pubTimestamp":1773077760,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Dow Jones","introduction":"Dow Jones publishes the world’s most trusted business news and financial information in a variety of media.","home_visible":0,"id":"106","head_image":"https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99"},"summary":"1336 ET - The FDA's new single-trial approval policy could expand pharmaceutical development pipelines, J.P. 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