When patient safety, regulatory approval and real-world effectiveness are on the line, AI can't act autonomously.

The pharmaceutical industry is experiencing its own “DeepSeek moment,” according to science writer Hiya Jain. Just as the upstart AI breakthrough caught Silicon Valley off-guard, China is emerging as ...

The collaborations will use Simulations Plus software platforms, including ADMET Predictor, GastroPlus, Thales, and ...

• Existing uses and current efficiencies: Artificial intelligence, including generative AI, is enhancing efficiency and effectiveness in trial design, patient recruitment and drug manufacturing, and ...

In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its work ...

Regulatory pressure from GxP, 21 CFR Part 11, and AI/ML guidance elevates requirements for audit trails, data lineage, ...

Oncologic drug development needs to place a greater focus on the patient, according to a commentary in the current issue of the New England Journal of Medicine. Even though the US Food and Drug ...

Yoo Chang-ho, head of strategy at SK Biopharmaceuticals, left, and Bae Min-seok, CEO of PhnyX Lab, pose for a commemorative photo marking the signing of a memorandum of understanding on AI-based drug ...