The FDA has released briefing documents detailing its concerns for AstraZeneca’s cancer drugs camizestrant and Truqap ahead ...
The advisory committee meeting—the FDA’s first drug-related adcomm in nine months—could have been a “more conceptual ...
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FDA Panel Gives Thumbs Down to Novel Strategy for Switching Breast Cancer Therapy
Panelists conflicted about positive trial's ability to validate biomarker-guided switching ...
ODAC voted 7–1 (one abstention) that capivasertib plus abiraterone and ADT shows a favorable benefit–risk profile for ...
In a move toward more transparency, the US Food and Drug Administration (FDA) on Friday announced it would publicly disclose the unredacted curricula vitae (CVs) of advisory committee members. A ...
While only about one in five US Food and Drug Administration (FDA) new drug approvals or safety decisions run counter to outside advisory committee advice, a new study published Monday in the Milbank ...
FDA leaders under President Donald 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 ...
FDA’s Digital Health Advisory Committee Weighs Guardrails for Generative AI in Mental Health Devices
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, ...
“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” ...
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 ...
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