BioSpace looks back at 2025 and where the FDA is going in 2026.
The FDA in 2025 was marked by a constant state of turmoil, from a massive workforce reduction that cut some 3,500 staffers and resulted in delays on new drug applications to reversals of guidance that led to surprise rejections. Then there was a leadership exodus that left just three veterans in the agency’s senior ranks and saw five different directors helm the agency’s most important division, the Center for Research and Drug Evaluation.
The new year has already seen its share of conflict. In a rare move last week, the FDA, in a letter signed by Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad, declined to review Moderna’s mRNA-based flu vaccine, mRNA-1010. The refusal-to-file letter directly contradicted previous guidance given to the company, CEO Stéphane Bancel said in a press release—highlighting a trend of FDA reversals of guidance that began last summer.
Here, BioSpace looks back at 2025 and where the FDA is going in 2026.
Lacking leadership stability
A year of unprecedented turnover at the FDA’s highest ranks has industry watchers calling for stability. The tumult started in March 2025 when longtime CBER head Peter Marks was forced to resign by Health Secretary Robert F. Kennedy, Jr., causing the S&P biotech index, the XBI, to plunge. There was a glimmer of hope when FDA veteran Richard Pazdur was tapped as CDER director after initially refusing the role but just weeks later, he announced his retirement.
This “historic leadership exodus . . . is likely to cause the most significant reshaping of agency direction in decades,” lawyers at Polsinelli Law Firm wrote in a BioSpace opinion.
When the leadership carousel finally stopped turning last year, known vaccine skeptic Tracy Beth Høeg sat atop as acting CDER chief. When asked by BioSpace in December, Chad Landmon, chair of Hatch-Waxman & Biologics at Polsinelli, wouldn’t hazard a guess as to whether she would be more than a placeholder.
Data source: FDA; Total remaining current as of Jan. 1, 2026
Regulatory action
Despite the staffing upheaval, the FDA greenlit 56 novel therapies last year, for cancer, neurological, rare diseases and more, a slight dip from the 59 it approved in 2024. Notably, the agency went against the decisions of its advisory committees on three of seven occasions in 2025, a considerably higher rate than the cumulative period of 2020–2024.
Data source: Jefferies analysis, Jan. 6, 2026
Policy meets politics
In 2025, the FDA issued more than 15 new policies and guidance. New vaccine regulations alarmed many in the industry—causing Moderna to rein in its late-stage efforts—while experts expect new guidance around cell and gene therapies (CGT) and rare diseases, along with expedited approval pathways, to drive new product approvals in 2026. Meanwhile, rare disease developers got another boost with the reauthorization of the previously stalled rare pediatric disease priority review voucher (PRV) program. CGT developers got another boost in January when the FDA carved out manufacturing exemptions intended to accelerate the path of these therapies to the market.
Unlike in previous years, however, the agency has been communicating policy through editorials, in scientific journals or through the press, often without a public comment period and typically lacking important details. Landmon said more guidance around these policies is needed.
Editor’s note: A version of this article was originally published as a special edition of ClinicaSpace on Feb. 16, 2026.
