Biodexa Receives US FDA Fast Track Designation for eRapa in Familial Adenomatous PolyposisUnderscores unmet need for a ...

The Fast Track designation accelerates troculeucel’s path to U.S. FDA submission for the treatment of patients with moderate Alzheimer’s ...

Biodexa has received US FDA Orphan Drug designation for eRapa in FAP and plans to seek a similar designation in Europe.

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

AstraZeneca and Daiichi's first co-developed ADC, Enhertu, was first approved by the FDA in 2019 for a type of ... its chief financial officer. category US consumer watchdog cases in limbo ...

The MosaiQ AiPlex CD is designed to improve the  accuracy and speed of celiac disease diagnosis while simplifying laboratory workflows EYSINS, Switzerland , Feb.

The US Food and Drug Administration (FDA) has authorised Zyn nicotine pouches to be sold to as a tool to quit smoking cigarettes. Thursday's decision allows 10 Zyn flavours, including mint ...

Part of the Trump administration's purge of the federal government included the removal of thousands of web pages. Now, some ...

Two U.S. legislators have introduced a bill that would give the FDA the ability to collect microbial samples at feed lots during foodborne illness ...

In November 2024, nearly two dozen Congress members sent a letter to the FDA officials demanding a ban on the dye. But the decision taken by the organisation also comes amid US President-elect ...

The FDA authorized the 20 Zyn products under a premarket tobacco product application process granted under a 2009 tobacco control law. Because Zyn includes nicotine, it must abide by the same ...

The US Food and Drug Administration authorised the ... the agency said in a statement. The FDA's move has set a "dangerous precedent", said Yolonda Richardson, president and CEO of the Campaign ...