A new study suggests clinical utility of the first FDA-approved genetic test to help gauge an individual’s risk for opioid ...

The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.

Since the announcement that president-elect Donald Trump would nominate Robert F. Kennedy Jr. (RFK Jr.) as the secretary of the U.S. Department ...

The Ministry of Food and Drug Safety announced ... considerations for the approval review process. The Ministry of Food and Drug Safety presented examples of medical devices corresponding to ...

This is just a sampling of medical advancements in 2024 chosen for their common presence in the American population. It is ...

DENVER, Jan. 27, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: ICU), a commercial-stage therapeutic medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on ...

This piece is part of a series that dives deeper into the most prevalent themes of this year’s iteration of our flagship research piece, Charting Disruption. Click to read.

Getting FDA approval was a long process – an earlier, bulkier version of the device was first submitted back in 2016 – but the company now intends to start shipping its first devices in the US ...

The Dekalb County Commission approved around ... a win to speed up the process of prosecution and conviction but most importantly to keep our people safe,” said Welden Welden says the department is ...

Bio-gene is not the only ASX life sciences play to bring germ warfare to the US military. The maker of Travelan, ...

The most common approval process for clinical trials using unapproved ... The Pharmaceuticals and Medical Device Agency (PMDA) offers consultation before clinical trial notification (CTN ...

Patented genetics from Charlotte’s Web were used in the process. There are very rare instances when cannabis-based drug candidates have achieved FDA approval, with only one containing cannabis ...