Tools · Sourced To Company Releases · Updated 2026-10-01

FDA Decision Calendar

Upcoming PDUFA target action dates, each one traced to the company press release that set it. Extensions are tracked on the row with the superseded date still visible, because a moved date repeated as current is the most common error on FDA calendars, and two of the widely syndicated dates were stale on the day this one launched.

When Is the Next FDA Decision?

CAPR (Capricor Therapeutics): the FDA's target action date for deramiocel in duchenne muscular dystrophy, refined to a proposed indication focused on upper limb function is November 22, 2026. A PDUFA date is a by-date rather than an on-date: the decision can arrive early, and a weekend date resolves by the preceding business day in practice.

Upcoming Decisions

This Week on the Calendar

The FDA dates that fall this week, day by day. A weekend action date sits on the Friday before it. Select a calendar to lay the earnings, economic data, Fed and lock-up calendars over the same five days, or download the week as one image.

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Week of October 5-9

Week 1 of 4

Mon

Oct 5

Data & events

Nothing scheduled

Tue

Oct 6

Data & events

Nothing scheduled

Wed

Oct 7

Data & events

Nothing scheduled

Thu

Oct 8

Data & events

Nothing scheduled

Fri

Oct 9

Data & events

Nothing scheduled

Times are Eastern. A lock-up marked * is dated from the prospectus day count and is approximate; an FDA date that falls on a weekend sits on the Friday before it, with the action date on the row.

Passed Dates

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How This Is Built

A date only appears here once it has been read in the company's own press release or filing, linked on the row. Aggregator calendars are used to find candidates and never to establish a date, because they demonstrably lag extensions: on the day this page launched, two syndicated dates were three months and one month stale respectively. When the FDA extends a review, the row keeps both dates, so a reader who saw the old one can see what happened to it.

The calendar deliberately covers a curated set: decisions on names this site covers, plus the largest pending approvals. It is not an exhaustive list of every generic and supplemental application, and it does not need to be to answer the question readers bring to it.

The whole calendar is available as JSON and CSV, licensed CC BY 4.0, with the source link and status carried on every row.

PDUFA Date FAQ

When is the next FDA decision date?
CAPR (Capricor Therapeutics): the FDA's target action date for deramiocel in duchenne muscular dystrophy, refined to a proposed indication focused on upper limb function is November 22, 2026. A PDUFA date is a deadline for the FDA to act, not a promise of approval: the agency can approve, issue a complete response letter, or extend the review.
What is a PDUFA date?
The date by which the FDA has committed to act on a drug application, under the Prescription Drug User Fee Act. Standard review targets ten months from acceptance; priority review targets six. The FDA can approve, reject with a complete response letter, or extend the date, most commonly by three months when a late submission is classed as a major amendment.
Do FDA decisions arrive exactly on the PDUFA date?
No. The date is a by-date, not an on-date: decisions regularly land days or weeks early, and dates that fall on a weekend resolve by the preceding business day in practice. Approvals have also arrived after the stated date without any formal extension.
Why do dates on this calendar differ from other FDA calendars?
Because extensions move dates and most aggregators are slow to catch them. When this calendar launched, two of the widely syndicated dates were stale: Savara's molgramostim had been extended from August 22 to November 22, 2026, and Cogent's bezuclastinib date is December 30, 2026, per the company, not the November 30 some calendars carry. Every date here links the company press release that set it. Last updated October 1, 2026.
What happens to a stock on a PDUFA date?
A binary event: approval opens a commercial launch, a complete response letter sends the company back for more work, and the stock reprices on whichever arrives. The move is usually largest for single-asset companies where the drug is most of the market cap, and smallest for label expansions on already-approved drugs at large companies.