New ALS drug enters human trials after reversing a key protein in animals and could change the future of treatment.

Commissioner Martin Makary and the outgoing director of the Center for Biologics Evaluation and Research (CBER) Vinay Prasad published an article in The New England Journal of Medicine,[1] in which ...

Simulations Plus is a global leader in model-informed and AI-accelerated drug development. We create value for our clients by accelerating the discovery, development, and commercialization of ...

New approach methodologies (NAMs) are emerging as an important tool in drug discovery, offering the pharmaceutical industry more predictive, human-relevant ways to evaluate safety and efficacy while ...

If the FDA approves a drug for a neglected tropical disease, the company gets a voucher that accelerates review of another drug. This remains controversial.

A collaborative study by the Tufts Center for the Study of Drug Development and CRIO identifies protocol interpretation and source document preparation as an understudied yet significant bottleneck in ...

Kelonia is developing technology to reprogram patients' T-cells inside the body so those cells can attack cancer, called in ...

Some psychedelic drugs, once considered fringe, are now getting a step closer to possibly being approved for use as mental ...

Artificial intelligence (AI) in healthcare has come to stay and is a well-recognised development over the last decade or so. AI has now progressed on to even the ability to execute quite a few tasks ...

Sriram Krishnan, Ph.D., Chief Product Officer at Target RWE; 20+ years building health tech, inventor on 28 patents, author of 30+ papers. As the chief product officer at Target RWE, a health ...

A Phase 3 trial found daraxonrasib nearly doubled survival in advanced pancreatic cancer, offering new hope ahead of FDA ...

Researchers studied heme synthesis in brown fat and found it was essential for thermogenesis and branched-chain amino acid ...