Dr. Reddy's Laboratories Pomalidomide FDA Approval August 31, 2026: Fifth PDUFA Approval of the Year
Dr. Reddy's pomalidomide application was approved on its August 31, 2026 PDUFA date — the company's fifth FDA approval of 2026 and 15th straight tracked approval since October 2024.
Dr. Reddy's Laboratories (RDY) received FDA approval on a pomalidomide application with a PDUFA target action date of August 31, 2026, when the action was completed — our tracked record shows the outcome as approval with an actual action date of August 31, 2026, matching the target date exactly. It is the company's fifth recorded PDUFA approval of 2026 and extends a tracked streak of FDA approvals in which every PDUFA-dated decision in our dataset for this company has ended in approval. This recap covers what our data verifies about the decision, what remains unknown, and the regulatory track record behind it — the company's market capitalization stood at roughly $9.9 billion in our snapshot at the time of writing.
What happened
The tracked event record states:
- Event type: PDUFA target action date.
- Expected (target) date: August 31, 2026, with "exact" date confidence.
- Outcome: approval.
- Actual action date: August 31, 2026 — the FDA completed the action on the target date itself.
- Product: pomalidomide (from the structured drug field; our system also resolves a canonical drug page for it).
- Known at: September 15, 2026 — the outcome entered our dataset two weeks after the action date.
Prepared research question
How would this research framework change the view of a company?
Traceable citations · Unknowns marked
What's verified
- Company: DR REDDYS LABORATORIES LTD, ticker RDY, active listing status.
- Approval: the outcome field records "approval" — the application cleared its PDUFA date as an approval, on the exact target date.
- Drug: pomalidomide, with a resolved canonical drug reference in our system.
- Company scale: Market capitalization of $9,912,563,712 in our snapshot.
- Institutional footprint (13F): as of quarter-end March 31, 2026, three institutions held filed positions totaling $23,203,589 — UBS Group AG (1,552,308 shares, $21,499,466), Greenleaf Trust (122,795 shares, $1,700,711), and Maseco LLP (246 shares, $3,412). Our data shows one quarterly trend point for the name. As with all 13F data, this captures US-institutional filings only.
What remains unknown
- The indication covered by this approval: our event record's indication field is empty — we do not state which use the approval covers.
- Application details: application number, review designation, and exclusivity terms are not in this event record.
- Commercial details: launch timing and pricing are not tracked in this dataset.
A note on timing and how this recap exists
Two dating facts in our record are worth separating. The action itself happened on August 31, 2026 — the PDUFA target date, met exactly. The outcome entered our tracking dataset on September 15, 2026, fifteen days later, which is when this event became eligible for a recap under our editorial gate: our system only writes retrospective pieces for events whose outcomes are recorded, and this pomalidomide decision is among the first to clear that bar. For readers arriving from search, that means the facts below have been stable since the action date, even though this recap is published after it.
Looking forward, our tracker currently shows no further PDUFA-dated event for Dr. Reddy's beyond the June 2026 prednisone record — the calendar ahead is, as of this dataset snapshot, unpopulated. New filings would appear on the company page as they are tracked.
The 2026 approval run and the longer streak
This approval is the fifth PDUFA-dated approval recorded for Dr. Reddy's in 2026, after:
- prednisone — target and action date June 26, 2026, approved
- venetoclax — May 15, 2026, approved
- nintedanib — April 2, 2026, approved
- dexmedetomidine — February 25, 2026, approved
Looking further back, our tracker holds fourteen prior PDUFA records for the company going back to October 2024. Every one of them carries an "approval" outcome in our data:
| Action date | Drug | Outcome |
|---|---|---|
| June 26, 2026 | prednisone | approval |
| May 15, 2026 | venetoclax | approval |
| April 2, 2026 | nintedanib | approval |
| February 25, 2026 | dexmedetomidine | approval |
| November 19, 2025 | nilotinib | approval |
| November 3, 2025 | linagliptin | approval |
| October 1, 2025 | prednisone | approval |
| July 3, 2025 | eribulin | approval |
| May 30, 2025 | phenylephrine hydrochloride in 0.9% sodium chloride | approval |
| April 11, 2025 | triamcinolone acetonide | approval |
| March 12, 2025 | triamcinolone acetonide | approval |
| February 19, 2025 | paliperidone | approval |
| October 29, 2024 | ticagrelor | approval |
| October 1, 2024 | varenicline | approval |
The drugs span oncology (venetoclax, nintedanib, eribulin, and the pomalidomide approval at the center of this recap), neurology (paliperidone, dexmedetomidine), respiratory and cardiovascular (ticagrelor, prednisone, phenylephrine), and diabetes (linagliptin, nilotinib) — a breadth that reads as a portfolio-scale regulatory operation rather than a single-program story. Counting from the October 2024 records through the June 2026 prednisone approval, the fourteen prior actions plus this pomalidomide decision average out to very roughly one FDA action every five to six weeks — a cadence our data records as fact through the dates themselves. We note again what the data does not say: our records do not classify the regulatory pathway for any of these approvals, and we will not label them beyond what the outcome field states.
How to track it
- Dr. Reddy's Laboratories company page — full catalyst calendar: https://biosniper.co/company/RDY
- This PDUFA event page: https://biosniper.co/calendar/event/2773459
- Pomalidomide drug page: https://biosniper.co/drug/pomalidomide
Bottom line
A pomalidomide application with an August 31, 2026 PDUFA date was approved on that exact date — the fifth such approval for Dr. Reddy's in 2026 and the latest in a fourteen-for-fourteen tracked record of PDUFA approvals going back to October 2024. The covered indication and application specifics are unknown in our data. For a $9.9 billion-market-cap company with three US institutions holding $23.2 million in filed 13F positions at the last quarter-end in our snapshot, the pattern our data shows is consistency: steady volume of FDA actions, each one ending in approval, with no exception recorded in nearly two years of tracking.