Device and pharmaceutical manufacturers must understand the differences in scientific expectations and cultural environments between CDRH and CDER to obtain FDA approval of drug-device combination ...

A Ludwig Cancer Research study has identified a combination of three existing drugs that significantly extends survival in mouse models of the lethal brain cancer glioblastoma multiforme (GBM).

Determining whether you have a cold, the flu or Covid-19 might be getting a little easier soon. On Friday, the U.S. Food and Drug Administration authorized the first over-the-counter combination test ...

Scientists in the United States have tested all possible pairings of the 100 cancer drugs approved for use in patients in order to discover whether there are any combinations not tried previously that ...

May 13 (Reuters) - Merck (MRK.N), opens new tab said on Monday it had discontinued an experimental combination treatment testing a new type of immunotherapy in patients with a severe form of skin ...

A new UCLA-led study has identified multiple new risk genes for Alzheimer's disease and a rare, related brain disorder called progressive supranuclear palsy (PSP) by using a combination of new testing ...

Many regulatory considerations may be unfamiliar to manufacturers pursuing market approval of combination products. Understanding and planning for these considerations can significantly affect FDA ...