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In the midst of regulatory and political upheaval, biopharma’s R&D engine kept running, churning out highs and lows in equal parts. Here are some of this year’s most glorious clinical trial victories.

As clinical research evolves, disruptive trial designs are reshaping how oncology advances. By integrating novel methodologies, strategic innovation, and patient-centered approaches, MEDSIR is driving a new era in cancer research, one that accelerates development, enhances efficiency, and delivers more meaningful therapeutic progress for patients worldwide.

With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former regulator insists that a “failed trial is not a failed drug.”

Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant, which it rejected last September, triggering a very public dispute with the company.

Every year in biopharma brings its share of grueling defeats, and 2025 was no different, especially for companies targeting neurological diseases. Some failures split up partners, and one particularly egregious case even led to the demise of an entire company.

The announcement was made at the International Society of Stem Cell Research (ISSCR) Symposium Accelerating PSC-Derived Cell Therapies: Starting with the End in Mind

The loss of domvanalimab is the latest in a string of high-profile failures recorded across the biopharma world for the TIGIT modality, including from GSK, Merck and Roche.