Rule could make more medications available over the counter through a process called Additional Condition of Non-prescription Use (ACNU).

The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug ...

The FDA has granted Cour Pharmaceuticals orphan drug designation for CNP-104, a biodegradable nanoparticle in development for ...

Metabolic medicines dominated life sciences headlines in 2024, a trend expected to continue into the new year. Other things to look for include more widespread adoption of artificial intelligence ...

Drug pricing is influenced by numerous factors, but technology has the potential to strike the critical balance between ...

The typical cost of developing new medications may not be as high as generally believed, with a few ultra-costly medications skewing public discussions about the cost of pharmaceutical research and ...

On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for ...

The FDA published its first draft guidance on the use of AI in the development of drugs and biological products ...

The FDA’s guidance on AI in drug development points to potentially life-threatening consequences of the technology, highlighting the importance of providing the regulator with detailed information ...

The science has proven that gene therapies are effective treatments, and they have given hope to patients and their families ...

Researchers at the University of Oklahoma have developed a breakthrough method of adding a single nitrogen atom to molecules, ...

Shares of IBD 50's GeneDx surged Monday after the Food and Drug Administration issued guidance about using AI to develop medical devices.