Drugmakers quickly adopt low-impact AI/ML models in quest to eventually automate manufacturing processes. Already, they are learning a lot about how these models can support their operations. One finding: innovative change management approaches may be required to unlock their full potential.

With the only FDA-approved treatment off the market, the FDA is looking for ideas for development of new preterm birth treatments.

The sprawling safety surveillance system is propelling advances in informatics and advanced analytics, but the agency is delaying next contracting cycle to digest its experience.

The launch of competition to Humira was the main event for US biosimilars this year – but a number of other key developments also took place in 2023, including settlements on Stelara that set up a series of launches in 2025, as well as first approvals for ustekinumab, natalizumab and tocilizumab biosimilars.