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).

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 ...

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

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