On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...

Securing FDA clearance or approval is a major accomplishment for medical device and pharmaceutical companies, but it’s not ...

Huxley Medical, a commercial-stage medical technology firm focused on streamlining detection of sleep and heart disorders, has received clearance from the U.S. Food and Drug Administration ...

Our experts explain the science behind red light therapy, and if it really works. Plus, we recommend some FDA-cleared wands ...

Supernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of ...

VIP was developed through a collaboration among the U.S. Food and Drug Administration (FDA), the Medical Device Innovation Consortium (MDIC), ISACA, and leading medical device manufacturers. The ...

Smart watches, rings, and a growing array of patches are adding more functionality and being used across a growing set of ...

The 10% tariffs on Chinese goods began Tuesday. China reacted with a 15% tariff on coal and liquefied natural gas and a 10% tariff on crude oil, agricultural machinery, large-displacement automobiles ...

The ACR-368-tailored OncoSignature assay is being used to predict patients most likely to respond to ACR-368 in Acrivon’s ongoing, ...

Acrivon Therapeutics said the Food and Drug Administration has granted Breakthrough Device designation for its ACR-368 OncoSignature assay, an immunofluorescence assay for the identification of ...

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug ...

The ranibizumab injection could be administered in a convenient schedule twice per year for the treatment of diabetic macular ...