Could This Treatment for Ulcerative Colitis and Crohn’s Disease Get Approved in Europe?
source: shutterstock.com

Could This Treatment for Ulcerative Colitis and Crohn’s Disease Get Approved in Europe?

According to reporting from News-Medical.net, Janssen-Cilag International NV recently announced that it had applied for European Medicines Agency (EMA) approval of its drug guselkumab (marketed as TREMFYA) in an expansion…

Continue Reading Could This Treatment for Ulcerative Colitis and Crohn’s Disease Get Approved in Europe?
New FDA Regulation on Laboratory Developed Tests Draws Objections from Healthcare Groups
source: shutterstock.com

New FDA Regulation on Laboratory Developed Tests Draws Objections from Healthcare Groups

As reported in Biopharma Dive, the FDA’s decision to strengthen its authority involving laboratory developed tests (LDTs) has drawn considerable objections from various healthcare groups. However, the Agency has held…

Continue Reading New FDA Regulation on Laboratory Developed Tests Draws Objections from Healthcare Groups