The FDA has released a draft guidance outlining how drug developers can validate new approach methodologies (NAMs) as alternatives to animal testing in preclinical drug development. The guidance, ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

Antibody-drug conjugates (ADCs) hold great promise as targeted cancer therapeutics. But their complex structure poses significant development and safety challenges for biopharma. In this GEN webinar, ...

PDA Publishes Revised Technical Report No. 56: A Clear, Phase Appropriate Roadmap for GMP Compliant Development of Biological Drug Substances Technical Report No. 56 (Revised 2026) outlines a ...

New clinical data from Phase 1 trial of ZW191 to be presented in an oral presentation on April 21Preclinical data highlight combination potential for ZW191, a folate receptor alpha (FR?)-targeting ant ...

Researchers have applied AI and machine learning to every stage of the drug development process. This includes identifying targets in the body, screening potential candidates, designing drug molecules ...

NCI has played, and should continue to play, an important role in the development of new cancer therapeutics. That role has changed and will continue to evolve as the basic science underlying cancer ...

At the Society for Neuroscience annual meeting in San Diego on November 20, Gain Therapeutics, Inc. (NASDAQ:GANX) unveiled new preclinical data on its lead drug candidate, GT-02287. GT-02287, a small ...

Polyrizon Ltd. (Nasdaq: PLRZ) ('Polyrizon” or the 'Company”), a pre-clinical-stage biotechnology company developing intranasal administrated solutions, today announced the signing of an agreement with ...