STAT+: Biotech execs, academic expert lament impact of FDA turnover on rare disease drug development
Executives in the biotech industry are expressing concerns over the recent turnover at the FDA, which they believe is affecting drug development for rare diseases. At a recent summit, Mahzi Therapeutics CEO Yael Weiss highlighted the anxiety investors feel regarding the agency's leadership changes. The uncertainty surrounding FDA personnel has led to a tumultuous environment for companies seeking drug approvals.
- ▪Biotech executives and an academic expert discussed the impact of FDA leadership changes on rare disease drug development.
- ▪Yael Weiss, CEO of Mahzi Therapeutics, reported that investors frequently question her about the FDA's recent turmoil.
- ▪The ongoing uncertainty at the FDA is creating a challenging environment for drug developers.
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| Original publisher | STAT |
| Canonical URL | https://www.statnews.com/2026/05/20/rare-disease-biotech-ceos-discuss-fda-uncertainty-stat-summit/?utm_campaign=rss |
| Publication time | Wed, 20 May 2026 17:00:07 +0000 |
| Retrieval time | 2026-05-20T17:05:02.733Z |
| Last seen | 2026-05-20T17:05:49.049Z |
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Opening excerpt (first ~120 words) tap to expand
STAT PlusBiotech Biotech execs, academic expert lament impact of FDA turnover on rare disease drug development ‘It’s a roller coaster,’ one CEO said of investors’ reaction to the leadership chaos Manage alerts for this article Email this article Share this article Mahzi Therapeutics CEO Yael Weiss, left, and Ted Love, the former chairman of BIO, spoke at the STAT Breakthrough Summit West in San Francisco.Jack Simpson for STAT By Lizzy LawrenceMay 20, 2026 FDA Reporter Lizzy Lawrence[email protected]Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health. Confidential tips can be sent on Signal at lizzylaw.53.
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