The International Society for Stem Cell Research (ISSCR) Consortium on Advanced Stem Cell-Based Models in Drug Discovery and Development has submitted comments to the U.S. Food and Drug Administration ...

The US Food and Drug Administration (FDA) has proposed guidance to reduce the need for animal testing in the development of ...

The U.S. Food and Drug Administration today issued a draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for certain cancer drugs. “This draft guidance not only ...

On February 23, 2026, the US Food and Drug Administration (FDA) released draft guidance outlining a new “plausible mechanism framework” that offers sponsors of certain individualized rare disease ...

On March 18, 2026, the Food and Drug Administration (FDA) issued draft guidance entitled “General Considerations for the Use of New Approach Methodologies in Drug Development.” The guidance is meant ...

The past year has marked a turning point for New Approach Methodologies (NAMs) in preclinical drug development. No longer experimental curiosities, these human-relevant approaches have rapidly gained ...

After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...

From spaceflight to high-throughput studies, evidence supports greater use of organ chips, but regulatory ambiguity and ...

On March 18 th, the FDA published draft guidance on validating new approach methodologies (NAMs), including complex in vitro models (CIVMs). For a field long operating without a clear regulatory ...

WASHINGTON, March 19, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA), a leader in innovative drug development and a vocal advocate for reducing unnecessary animal testing, ...

The FDA is looking to get thrifty with its approved drugs. Through a newly proposed repurposing initiative, the agency hopes to help address unmet medical needs by finding new uses for ...

The US Food and Drug Administration (FDA) has published a new report calling for a new drug regulatory decision-making paradigm for risk-benefit assessments, rejecting calls for a quantitative-only ...