The first half of 2025 has been a busy time for novel drug approval news, and these developments signal not only the continuing advances in medicine that we see across specialty areas, but also the promise of a future with more precision and diversity. From new targeted treatments for cancer to breakthroughs in rare diseases, this wave of approvals marks a clear direction for the future of health care.
As usual, monoclonal antibodies (mAbs) have been the most prolific class of drugs approved this year. The FDA has authorized 12 mAbs to date, including glofitamab-gxbv (ColumviTM), a bispecific CD20/CD3 T-cell engager for multiple myeloma; faricimab-svoa (VabysmoTM), a mAb that targets BMA on cancer cells and CD3 on T-cells; and blinatumomab (BlincytoTM), which targets ADC tetramers and the tumor-inhibiting PD-L1 protein.
It’s been a challenging year for the FDA since Commissioner Makary arrived in April, and he’s been pushing staff to challenge assumptions and rethink procedures. He’s pushed back against the truncated process used to authorize the first COVID-19 vaccines and has said that all future vaccines will be required to undergo full testing with a placebo. He’s also promised to make it easier for companies to get their drugs through the accelerated approval program. But can he do so while still maintaining the FDA’s credibility?