The administration said it is fast-tracking clinical trials that would allow patients struggling with serious mental health ...

But three of those FDA employees told CNN that Elsa just makes up nonexistent studies, something commonly referred to in AI ...

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is getting better, and use is not mandatory.

A dozen lawsuits have been filed over spinal cord stimulators, which are medical devices surgically implanted to reduce chronic back pain. The suits name device manufacturers, such as Abbott and ...

Nootropics are substances that enhance cognitive performance through various mechanisms, including cholinergic, glutamatergic, and dopaminergic pathways. They include prescription medications, natural ...

For decades, the Food and Drug Administration has been notoriously tight-lipped about why it rejects drugs. It has remained ...

The Swiss company, which markets Elevidys abroad, said it believes the benefit-risk balance to treatment remains positive in ...

D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment ...

Aquestive Therapeutics, Inc. (NASDAQ: AQST) ('Aquestive” or the 'Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science ...

The abstracts accepted for mini oral presentations include updated efficacy and safety data from the Phase 2b REZILIENT1 ...

The FDA action is in line with US Department of Health and Human Services Secretary Robert F. Kennedy, Jr.’s priority to work with industry to phase out the use of all synthetic, petroleum-based dyes ...