The FDA issued draft guidance Jan. 21 proposing the use of minimal residual disease and complete response as primary endpoints to support accelerated approval of drugs for multiple myeloma. The draft ...

In a somber end to an FDA advisory committee’s two-day scouring of multiple drugmakers’ oncology data, Pfizer’s pitch to expand Talzenna into a broader prostate cancer population has failed to impress ...

Experts from Philip Morris International (PMI) (NYSE: PM) yesterday presented scientific evidence to the U.S. Food and Drug Administration’s (FDA) Tobacco Products Scientific Advisory Committee (TPSAC ...

Johnson & Johnson has won the support of an FDA expert panel in its bid to make Darzalex the first treatment for an early form of multiple myeloma despite uncertainties raised by regulators. The FDA’s ...

The researchers found that 48% of speakers are patients and family members, 99% of whom support drug approval. HealthDay News — Most speakers attending US Food and Drug Administration (FDA) Human Drug ...

On November 6, 2025, the U.S. Food and Drug Administration's (FDA) Digital Health Advisory Committee (DHAC) convened for the second time since its inception to explore the regulatory pathways, ...

FDA leaders under President Trump are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency's decisions from public ...

On Tuesday, a U.S. Food and Drug Administration advisory committee voted unanimously that the oral formulation of a very common nasal decongestant, phenylephrine, is not effective. The decision could ...

“What’s that? (I may be paranoid, but no android),” Radiohead once sang. That familiar tension between human judgment and technology echoes strong in today’s debate about artificial intelligence (“AI” ...