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 ...

Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...

Advances in drug discovery and clinical research have shifted the bottleneck in medicines development to chemistry, manufacturing, and controls activities, a critically step for regulatory approval.

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 ...

The potential of using artificial intelligence in drug discovery and development has sparked both excitement and skepticism among scientists, investors and the general public. Researchers have applied ...

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 ...

While agents like AbbVie's Humira have transformed the treatment landscape, not all patients benefit equally from the drug.

A new procedural document issued by the US Food and Drug Administration (FDA) instructs its staff on the best practices-known as Good Review Practices (GVPs)-used in the review of investigational new ...

As pipelines across modalities diversify, regulatory scrutiny intensifies, and the margin for error in development execution continues to shrink, partnering with a CDMO has never been more critical.

CHARLOTTETOWN, Prince Edward Island--(BUSINESS WIRE)--Today BIOVECTRA celebrates the completion of its $90 million plus biologics expansion at the company’s new state-of-the-art Biomanufacturing ...

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 ...