Commissioner Marty Makary announced plans to roll-out a new approval pathway for rare disease drugs. Commissioner Makary’s comments build on sentiments expressed across both the patient community and ...

Accurately predicting the success of clinical trials is crucial for optimizing resources and improving the development process of new ... can predict clinical trial approval rates accurately ...

In the fifth episode of a six-part interview series on immunotherapy, Marc Voigt, CEO and Executive Director of Immutep (ASX:IMM), explains the complex and heavily regulated process of bringing a new ...

Multiple vaccine-related petitions that have been filed before courts reflect growing concerns about how vaccines are approved and administered in India ...

In Japan, it is quite rare for an investigator to submit an investigational new drug application to initiate a clinical trial and obtain approval of a drug on the basis of clinical trial results.