Clinical Trials
What Are Clinical Trial Phases in Drug Development?
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.
Generics and biosimilars
A generic medicine contains the same active substance as an approved product and reaches market by demonstrating equivalence rather than by repeating the original trials. A biosimilar is the equivalent for a biological product, and cannot be an exact copy — biologics are defined partly by how they are made — so it follows a distinct and more demanding comparability route.
We cover both because they are the mechanism through which established treatments become affordable, and because the difference between the two is routinely blurred in reporting on drug pricing.
Biotechnology
Biotechnology in Healthcare: How Biotech Works
How biotechnology companies develop new treatments: biologics, monoclonal antibodies, mRNA, cell and gene therapy, manufacturing, funding, and regulation.
Drug Regulation
FDA Explained: What the U.S. FDA Does
What the FDA does: regulating medicines, biologics, medical devices, food and tobacco, how review and inspection work, its centres, powers and known criticisms.
Drug Regulation
How New Medicines Are Approved: FDA and EMA Paths
FDA and EMA regulatory pathways compared: standard and expedited routes, evidence requirements, decision structures, and why approvals differ between regions.