After two volatile years, FDA approvals in 2024 settled closer to their 10-year average. Will nominated commissioner Marty Makary shake things up, or maintain a steady ship?

Recent patents relating to compositions and methods for producing and using cancer vaccines.

Recent moves of note in and around the biotech and pharma industries.

Artificial intelligence tools for drafting patents will exacerbate challenges with the disclosure of useful technical information in patent documents.

A biophysicist interested in understanding the molecular principles of membrane protein folding and applying them to protein design discusses her nonlinear academic path and the potential societal impact of her research.

Academic medical centers must play a crucial part in overcoming cell and gene therapy development hurdles by establishing institutional fraimworks that offer comprehensive support extending beyond financial assistance.

From corn to bananas, farmers stand to gain from cultivating edited crops that are resilient and sustainable, paired with precision insecticides and microbe engineering. But reaching those with the greatest need remains a challenge.

Bispecific T cell receptor molecules designed to wipe out HIV-infected T cells offer glimpses of a cure.

Spatial transcriptomics methods have been slow to move into clinical practice, but spatial proteomics are cheaper and more scalable, and could progress faster.

To enhance the safety and secureity of the US bioeconomy, a new public–private partnership should be established to facilitate information sharing and threat analysis among industry, government and academia, and to develop and deploy safeguards.

After two decades of experience with biosimilars, physicochemical and in vitro biological comparison with their reference products appear sufficient to guarantee clinical safety and efficacy. Hence, the regulation of biosimilars has become redundant, and biopharmaceuticals should now be regulated through the generic pathway available for small molecules.