Track Upcoming FDA Approval Calendar and PDUFA Dates Before the Market Moves

Get real-time access to the FDA calendar, which covers PDUFA dates, FDA panel review dates, and FDA approvals, designed for biotech traders and investors.

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Sample From Our Live FDA Calendar 500+ events tracked — Subscribers See All Upcoming Events in Real Time
Drug
Company Name
Date
Event
Nanoecapsulated Sirolimus plus Pegadricase (BLA)
Swedish Orphan Biovitrum AB (SWOBY, BIOVF, SOBI.ST)
06/27/2026
FDA decision on Nanoecapsulated Sirolimus plus Pegadricase (NASP) to treat uncontrolled gout.
LNTH-2501 (Ga 68 edotreotide), a PET Diagnostic Imaging Kit (NDA)
Lantheus Holdings Inc. (LNTH)
06/29/2026
FDA decision on LNTH-2501 for use with PET imaging for localization of somatostatin receptor-positive (SSTR+) neuroendocrine tumors in adult and pediatric patients.
ZORYVE cream 0.3% (sNDA)
Arcutis Biotherapeutics Inc. (ARQT)
06/29/2026
FDA decision on ZORYVE cream 0.3% to expand indication for the topical treatment of plaque psoriasis to include children 2 to 5 years old
Oxylanthanum Carbonate (Resubmitted NDA)
Unicycive Therapeutics, Inc. (UNCY)
06/29/2026
FDA decision on Oxylanthanum Carbonate for the treatment of hyperphosphatemia in CKD patients on dialysis
Olezarsen (sNDA)
Ionis Pharmaceuticals, Inc. (IONS)
06/30/2026
FDA desicion on Olezarsen for the treatment of severe hypertriglyceridemia
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500+ upcoming FDA dates
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Every FDA Event That Moves Biotech Stocks

Key FDA catalysts that can significantly impact biotech stock prices.

PDUFA Dates

Target dates for FDA approval decisions.

AdCom Meetings

FDA Advisory Committee review of the applications

Complete Response Letters (CRLs)

When the FDA rejects an application

Fast Track & Breakthrough Designations

Accelerated review pathways

Accelerated Approvals

Conditional approvals for serious unmet medical needs

Label Expansions

Approvals for new indications on existing drugs

Our Track Record

FDA & Clinical Trial Catalysts We Tracked — and What Happened Next

Stock Featured Date Price Then Recent High Gain
LQDA Oct 17, 2025 $22.59 $62.17 (May 20, 2026) +175%
CGON April 28, 2025 $31 $75.50 (May 14, 2026) +144%
PRAX June 04, 2025 $41 $358.76 (May 13, 2026) +775%
ANAB April 28, 2025 $13.87 $72.36 (May 05, 2026) +422%
ORKA Sep 18, 2025 $16.21 $91 (Apr 27, 2026) +461%
These stocks were in our FDA Calendar and Clinical Trial Tracker ahead of their catalyst events. We don't make buy/sell recommendations — we track the events that move stocks so you never miss a catalyst.

Your FDA Calendar Subscription Includes

Everything biotech investors need to track FDA catalysts, clinical trials, and market-moving events.

FDA Calendar PRIMARY ACCESS

Full access to upcoming PDUFA dates, AdCom meetings, CRLs, and FDA approval decisions across 500+ biotech companies.

Clinical Trial Calendar BONUS

Phase 1, 2, and 3 trial readout dates included free. Track binary trial events alongside FDA catalysts.

Biotech Stocks On The Move BONUS

Daily updates on biotech stocks moving on news, catalysts — delivered before the broader market reacts.

Breaking Biotech News BONUS

Real-time corporate announcements from Nasdaq and NYSE-listed biotech and pharma companies.

M&A & IPO Alerts BONUS

Mergers, acquisitions, and IPO monitoring across the biotech sector.

Industry Event Coverage BONUS

Coverage of ASCO, ASH, JPM Healthcare, and other industry conferences that move biotech stocks.

Upcoming FDA Approvals & PDUFA Dates Tracker

RTT Biotech Investor helps traders and investors track market-moving biotech catalysts with a comprehensive FDA approval calendar/ PDUFA dates tracker

Stay ahead of critical biotech and pharmaceutical regulatory events, including:

Upcoming FDA approvals

PDUFA dates

Advisory Committee (AdCom) meetings

Our biotech FDA calendar provides timely updates on regulatory decisions that can significantly impact biotech and pharmaceutical stocks.

Track Biotech Stocks With Upcoming Catalysts in Real Time

By the time major biotech news hit mainstream platforms, the opportunity is already gone.

Market-Moving Events Happen Fast

FDA approvals, clinical trial results, acquisitions, etc. can move stocks overnight.

Early Signals Are Hard to detect

Critical insights are buried in complex data and financial noise.

Late Information = Missed Profits

Reacting after the news breaks means you're already behind.

Don’t react late. Stay ahead.

Built for Active Biotech Investors and Traders

Active traders positioning around binary catalyst events
Long-term biotech investors tracking portfolio holdings ahead of regulatory decisions
Healthcare-focused funds and analysts needing comprehensive coverage in one place

Get the Insights That Move Biotech Stocks—Before Anyone Else

RTT Biotech Investor delivers early, actionable intelligence on the catalysts that drive biotech stocks. Act with confidence before the broader market reacts.

Early Catalyst Alerts

Be the first to know about FDA decisions, and Clinical trial results.

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Why RTT Biotech Investor Is Different

Feature RTT Biotech Investor Free Sources (FDA.gov, ClinicalTrials.gov)
FDA Calendar All upcoming PDUFA, AdCom, CRL events in one place Scattered across multiple databases
Real-time alerts Yes, delivered to email and dashboard No — manual checking required
Clinical trial readouts Phase 1, 2, 3 dates pre-tracked Manual search across thousands of trials
Context & analysis Curated insights on each event Raw data only
Stock impact coverage Direct ticker linkage None
Time to monitor Minutes per day Hours per week

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Frequently Asked Questions

A PDUFA date is the FDA's target deadline for reviewing a new drug application submitted by a biotech or pharmaceutical company.

PDUFA dates are typically tracked 6–10 months in advance, with regular updates as catalysts approach.

We cover FDA events across large, mid, and small-cap biotech and pharmaceutical companies — including names that other services overlook.

This offering is designed to support both beginners and experienced investors. Whether you’re just starting out or already have market experience, the insights and tools provided are tailored to help you make more informed investment decisions at any stage of your journey.

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RTT Biotech Investor stands apart from free news by focusing on early catalyst detection, backed by proactive, actionable intelligence - delivering insights you can act on before they are widely reported.

You'll receive updates on a regular basis, ensuring you stay informed with timely insights and never miss important market-moving developments.

You’ll receive a mix of timely catalyst alerts, in-depth analysis, and actionable signals—giving you both the context and direction needed to identify and act on high-potential opportunities.

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