It's the latest stride by Nvidia and the pharmaceutical industry to harness AI to try to reduce costs and shorten the time it ...

The draft guidance, which is touted as a way to reduce the cost and time-associated burden of biosimilar development, has ...

The US Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...

So far, the USFDA has approved 76 biosimilars but the market share of these remains below 20% with only 10% of the biologics ...

The United States has said it will speed up approval for some generic drugs. The development comes weeks after it was ...

The FDA said it proposed significant changes to simplify biosimilarity studies and reduce what it described as unnecessary ...

Sai Life Sciences announces the groundbreaking of a state-of-the-art CMC Process R&D Center in Hyderabad, poised to double ...

Company highlights its global expertise and new and expanded capabilities to help biopharma and biotech customers solve global health challenges Thermo Fisher Scientific Inc., the world leader in ...

The FDA’s new draft guidance aims to make the approval process faster and less burdensome by limiting the need for ...

Eva-Maria Hempe, NVIDIA, says bio/pharma must centralize AI strategy, tackle silos, prioritize process integrity, and balance quick wins with long-term drug design goals.

If approved, it would be the first major new drug treatment for Parkinson’s in half a century. Richard Mailman, a University ...

A proposed move by the US Food and Drug Administration (FDA) to accelerate development and ease approval of biosimilars could ...