At CTO West Coast, an expert discussed the implications of the FDA’s expedited approval programmes with a spotlight on ...

While sparking excitement among biopharma companies focused on rare and ultrarare indications, experts say FDA Commissioner ...

No longer will our medicines be gated through animals, but rather through entirely human systems — leading to breakthrough ...

From virtual monitoring and eConsent to AI-driven image analysis, technology is revolutionising the drug development pathway. And now that the evidence base is catching up with digital ...

The FDA Fast Track and Accelerated Approval pathways have major implications for the wider healthcare landscape beyond drug development. Pharmaceutical companies can benefit from the FDA Fast ...

The pathway continues to play a critical role ... the importance of developing novel endpoints for more efficient drug development. c. Withdrawal procedures. The Accelerated Approval Guidance ...

Between 70% and 90% of drug ... molecular pathways involved in these disorders. Singh asserts that using AI to streamline the process is a “win-win” for all since the development phase ...