The agency is missing deadlines and not responding to biotech companies, forcing some to push back clinical trials.

This is a groundbreaking step toward advancing public health by using more effective and human-relevant methods instead of ...

In recent weeks, biotech companies have faced setbacks in moving forward with clinical trials due to operational delays at the FDA, according to an exclusive report from The Wall Street Journal ...

The FDA announced a shift away from animal testing for drug approval, citing advanced alternatives like AI and organoids ...

A new scientific breakthrough may soon offer hope for people affected by Alzheimer’s disease. A group of researchers in Spain ...

So, the first step toward success involves creating a ... I’ve never yet encountered a drug development organization that doesn’t want to be successful. However, many fail to recognize that ...

In an hour-long meeting at Eli Lilly and Company’s headquarters in Indianapolis on April 15, the pharmaceutical company’s top ...

Antibody-drug conjugates (ADCs) offer a sophisticated solution ... As a result, ADC manufacturing demands meticulous process development upfront. Every step – from antibody production and payload ...

and requires the FDA to publish a final rule to implement the FDA Modernization Act 2.0 (FDAMA 2.0) by updating regulations that allow for non-animal test methods that can better predict drug ...

The bipartisan FDA Modernization Act 2.0, which became law in 2022, paved the way for the latest step at ... to improve drug ...

The Food and Drug Administration (FDA) announced Thursday it plans to phase out animal testing requirements for biological ...