How Are New Drugs Developed? Discovery to Approval
How new drugs are developed: target discovery, preclinical testing, clinical trials, regulatory review by FDA and EMA, manufacturing, and post-approval monitoring.
Bringing a medicine from a promising molecule to a prescription takes years, costs a great deal, and fails far more often than it succeeds. The sequence — discovery, preclinical work, phased trials, regulatory review, manufacture — exists to find the failures before patients do.
We report on where candidates fail and why, how long each stage takes, and how the economics of development shape which diseases get attention.
How new drugs are developed: target discovery, preclinical testing, clinical trials, regulatory review by FDA and EMA, manufacturing, and post-approval monitoring.
The drug development process from laboratory research to patients: translational research, decision gates, who does what, and how a medicine reaches clinical use.
Clinical trial phases in drug development: what evidence each phase produces, how go/no-go decisions are made, and how phases differ for biologics and vaccines.