What’s on the calendar, and how to read it.
The Drug Pipeline Calendar is a Pro feature. This guide describes the full calendar; forward-looking catalysts are not included. Contact us about access.
One calendar for every public milestone in a drug’s trip through the FDA: the day the FDA is due to decide, when its outside advisers meet, when the key trials are expected to read out, and what was just approved or rejected. Everything is public information, and every entry opens a panel that shows you the document it came from.
It is built for the question a buy-and-bill team actually asks: what is coming, when, and how sure are we? So each entry carries not just a date but where that date came from and how firm it is.
Every chip on the calendar is one of these. Color tells you the type; the tag tells you how firm the date is. Open any chip and the panel also carries a plain-language card for the molecule itself — what it is, its class and mechanism, and what it treats.
The day the FDA has told the sponsor it aims to decide by — the single most planned-around date in the industry.
Each date is shown with the sentence it was disclosed in, a link to that disclosure, and the company that disclosed it.
A public meeting where an outside FDA panel reviews the drug and votes a recommendation — typically 2–3 months before the decision.
Shown with the committee and the proposed indication. Cancelled and postponed meetings stay listed and labeled — the change is itself news.
When a late-stage trial is currently expected to reach its primary results — the event that decides whether a filing happens at all.
Projected from what the sponsor itself expects. Most give only a month, so they sit in the band above the grid rather than on a day. Drawn dashed, always.
A new drug — or a new indication for an existing one — cleared for marketing.
The panel shows the application’s full approval history, its products, and the FDA’s own letter, label and review documents.
FDA saying, in its own words, that a product cleared — and the only place biologics licensed by CBER appear at all: cell and gene therapies, vaccines and blood products have no record in the FDA’s drug approval data and never will.
Shown with FDA’s own announcement. Where an approval is already on the calendar, the announcement attaches to that chip instead of making a second one.
A company announcing its own approval the day it happens — days before FDA’s data publishes it. Dashed, because it is the sponsor’s account and nothing official confirms it yet.
Checked against the FDA’s own record daily. Once FDA publishes the action the chip disappears into the approval chip as a badge on it.
The FDA declining to approve an application as submitted. Rarely the end of the story — most sponsors resubmit.
The panel carries the FDA’s letter itself, including a plain summary of why it could not approve, the statutory one-year resubmission deadline, and for still-open cases the window a next decision could fall in.
A sponsor announcing it has submitted an application, that the FDA accepted it for review, or that it has been withdrawn.
It confirms something is pending — it does not carry a PDUFA date.
The day-to-day tail: generic (ANDA) approvals, ordinary manufacturing supplements and tentative approvals. Hundreds a month, so it shows as a per-day count instead of chips — and is hidden until you ask for it.
Turn it on with the “Routine (ANDA / suppl.)” checkbox in the sidebar, or click any day number to see every action that day.
Eight places where the obvious reading is the wrong one. They matter more than anything else on this page.
Updated every morning. The “Data through” stamp beside the page title is the day the calendar is current to, and it reports the oldest of the sources behind it — the calendar is only as current as its stalest source, so one falling behind shows here even while the rest ran this morning.
The stamp turns amber when a source is running behind, and reads “freshness unknown” rather than showing a date if one has never reported at all — a plausible date would be worse than an honest gap.
Informational only. Nothing here is investment or clinical advice, and dates that have not yet happened can change without notice.
