Hemarsh Upadhyaya / Essays
The Shape of Drug Development
Forty years of FDA CDER novel drug approvals, in one place. This visual essay examines what was approved, when it was approved, which regulatory pathways shaped the record, and where development activity has concentrated.
Approval waves
Novel drug approvals do not rise in a smooth line. The record moves through surges, dips, and recoveries, including a mid-1990s peak, a lower stretch in the late 2000s, and a higher floor from the mid-2010s onward.
NDAs and BLAs
The essay separates CDER approvals by application type to show how biologic BLAs became a steady part of the annual approval mix alongside small-molecule NDAs. CBER-only biologics are outside this view.
The acceleration layer
Priority review, accelerated approval, fast track, breakthrough therapy, and QIDP designations are shown as regulatory signals layered onto the approval timeline. The patterns are descriptive and do not imply that a pathway caused an approval.
Where approvals cluster
Therapeutic area classifications show that approvals cluster around disease areas such as oncology, infectious disease, hematology, cardiovascular and specialty products, with the mix changing across five-year windows.
How they are delivered
The dosage-form view shifts attention from molecules alone to the practical form that reaches patients: injections, tablets, capsules, solutions, inhalers, patches, and other delivery forms.
The latest cohort
Recent approvals are handled separately so completed annual extracts and provisional year-to-date records are not read as equivalent. The 2026 data is provisional until FDA publishes a final calendar-year report.
What this essay does and does not show
The essay uses a reproducible local snapshot of public FDA CDER novel drug and new biologic approval data. It is not medical advice, not investment advice, and not a complete view of every approved drug.