Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. WASHINGTON — The Food and Drug ...

The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...

Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...

The FDA granted Priority Review to the supplemental New Drug Application (sNDA) for lurbinectedin in combination with atezolizumab as a first-line maintenance treatment for patients with ...

With a Trump-driven reduction of nearly 2,000 employees, agency officials view artificial intelligence as a way to speed drugs to the market. By Christina Jewett The Food and Drug Administration is ...

The US Food and Drug Administration’s longtime oncology chief has filed to retire from the agency just weeks after he was chosen to lead the FDA’s drug division, according to four people familiar with ...

ABC News' Dr. Tara Narula shares what patients need to know. Most compounded versions of popular drugs used for weight loss including Wegovy and Zepbound may soon no longer be available after a U.S.

The FDA is reviewing the supplemental BLA for lisocabtagene maraleucel (liso-cel), a CD19-directed genetically modified autologous T cell immunotherapy, for relapsed or refractory (R/R) marginal zone ...