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One of the first to benefit was Turkish toddler Hulusi Sert, four, who was administered the treatment last month in Dubai, ...

FDA nonmedical wearable health data devices providing general health info will not face regulation, clarifying guidance for ...

Echoing President Donald Trump’s call to accelerate medical innovation, Food and Drug Administration (FDA) Commissioner Marty Makary announced that the agency will no longer block companies from ...

The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.

Annalisa (Nalis) Merelli is a contributing writer at STAT focused on boys’ and men’s health. Exactly a month after it announced the removal of black box warning labels on estrogen therapy products ...

In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical decision support tools that don’t fall under medical device oversight.

The U.S. FDA’s final guidance for clinical trial inspections conducted under the bioresearch monitoring (BiMo) program seems to deviate little if at all from the 2024 draft, but that is precisely the ...

Forbes contributors publish independent expert analyses and insights. Gary Drenik is a writer covering AI, analytics and innovation. We’re entering a new era of prescription drug access. The local ...

Dec 11 (Reuters) - EU Council and Parliament negotiators have reached a provisional "pharma package" deal to modernize medicine rules, speed patient access and bolster competitiveness, the Council ...

SAN FRANCISCO--(BUSINESS WIRE)--Mandolin, the leading AI automation platform for specialty drug access, announced that it has raised $40 million in funding from Greylock Partners, SignalFire, Maverick ...

My time at the Pentagon clearly demonstrated that national security isn’t just about missiles and military readiness. It’s about the people and critical systems that keep Americans safe and healthy.