When pharmaceutical companies develop a novel drug for the market, several steps are required to assess and regulate its safety, effectiveness, manufacturability, and reliability. These processes, and ...

Global harmonization of CMC guidelines is a key focus for top pharmaceutical consultants. Variations in regulatory requirements across regions often create inefficiencies in drug development—for ...

With oral cyclic peptides offering small molecule convenience and antibody‑like selectivity, the modality is gaining momentum ...

A new two-step method makes more uniform antibody-drug conjugates by attaching cancer drugs at a precise antibody site, ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

In my previous article, I discussed how AI is rapidly transforming the drug discovery process, significantly accelerating timelines and reducing costs. However, while AI's potential in this domain is ...

Some drugs may seem like they were named by throwing darts at the alphabet – but the process of drug naming is actually very intentional. In an interview with Fox News Digital, Dr. Dave Latshaw, CEO ...

Eli Lilly and Nvidia are partnering to build what the companies call the pharmaceutical industry's "most powerful" supercomputer and so-called AI factory to help accelerate drug discovery and ...

This Brush Up is sponsored by MilliporeSigma. Learn more about therapeutic synthesis pathways. Drug development is a process that spans many years, from the initial phase of identifying potential drug ...