Brenner, who has worked in the FDA’s Center for Devices and Radiological Health, will lead the agency until a permanent ...

The FDA rejected the company’s initial NDA in 2021, citing the lack of an adequate trial to demonstrate efficacy.

Up to €37.5m of Median’s funding comes from the EIB, and €10m from an equity line with IRIS Capital Investment.

This is the latest venture for Amylyx into the ALS field after its previous therapy Relyvrio was pulled from the market in ...

Danica Patrick and Amy Earnhardt applaud FDA's Red #3 ban, promoting healthier, additive-free choices for consumers.

Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product development, ...

“We are proud that our advanced modeling and simulation software and consulting services supported the development of the ...

Weight loss is a highly personal journey. Just as there is no one reason for wanting to lose weight, there is also no ...

or whether NHS R&D and NHS REC approval is required, and seek guidance from them as to the subsequent application process. The NICR panel meets regularly throughout the year to consider ethical ...

Regulated by authorities such as the FDA as ‘Software as a Medical Device’ (SaMD), PDTs are reshaping psychiatric ... and are subject to FDA review as part of the drug’s approval process. This offers ...

Explaining the deferral, committee chairwoman Jackie Meade said the decision was “to ensure the full process is followed to its full extent ... the plan had been recommended for approval subject to ...