FDA's plan to deploy an AI tool to assist with scientific review process raises questions about transparency and risks.

The US Food and Drug Administration (FDA) has set an "aggressive" timeline to implement genAI across the agency by 30 June ...

The use of RWD data in place of placebo groups is improving various elements across the clinical trial space.

Vienna, Austria – May 9th 2025 – Biomay, a leading manufacturer of recombinant proteins, today announced the commercial availability of its CRISPR/Cas9 nuclease, marking a significant addition to its ...

Donald Trump has promised to create a pro-AI environment, but even tech companies are frustrated by federal cuts that hamper regulatory processes. Paul Webster reports.

The U.S. Food and Drug Administration said on Thursday all its centers will deploy artificial intelligence internally ...

Because price and margin headwinds exist predominantly in small-molecule oral tablets that are easy to produce, we expect Viatris’ future pipeline to focus more on complex generics—drugs that have ...

The Food and Drug Administration on Thursday announced an aggressive agency-wide Artificial intelligence adoption timeline ...

The U.S. Food and Drug Administration (FDA) on Thursday announced an expedited plan to implement artificial intelligence (AI) ...

The Food and Drug Administration is going all in on artificial intelligence. | The Food and Drug Administration is going all ...

The FDA is looking into how AI could help with final drug approvals and improve internal tasks like checking whether an ...

The FDA has appointed its first chief artificial intelligence officer, with an eye on supporting the agency’s internal IT ...