PDUFA Calendar

FDA Approval and a complete biotech catalyst calendar can be found HERE.

Advisory Committee
PDUFA Priority Review

About the author

Currently residing in New Zealand, Mr. A.Burden holds a Master of Commerce in International Business from the University of Sydney and used these skills together with his passion for investing to establish BioPharmCatalyst in June 2010 as a tool for investing decisions in the US pharmaceutical market. He spends much of his free time mountain biking, playing squash and hiking.

85 Responses to “PDUFA Calendar”

  1. Daniel says:

    I am a very happy visitor of your site. You have one of the most refined calendars out there, and i’m grateful of the hard work you do. I’d love to contribute to you if you have a paypal or another link. Also, do you have a google calendar, or a RSS feed for the calendar available?

  2. admin says:

    Thanks for the feedback Daniel. Donations are most appreciated. As luck would have it I have a DONATE button on all pages except this page! You’ll find it as a green button. All additions to the calendar are noted in the title when I post an article and there is a RSS feed available. However, I haven’t got one set up just for the calendar. If you’re on twitter I also tweet out new PDUFA dates. Unfortunately no google calendar.

  3. Nilesh Patel says:

    Really appreciate the hard work in accumulating the details and arranging in orderly fashion.

  4. Ben says:

    Hi. there are some PDUFA dates in August that are missing from the calendar.

  5. Ben says:

    Sorry, only one – PDUFA set for 27 August 2012 for Gilead’s Quad HIV pill.

    Thanks for the great job.

    • admin says:

      Thanks Ben. Done. I generally only keep an eye on stocks sub $25, hence the reason for GILD not being on the calendar. Nothing against large-cap companies, but I have to draw the line somewhere to manage my workload…but of course if I hear of a PDUFA date from a reader that I haven’t listed then I will most certainly add it to the calendar!

  6. Brian says:

    The Smaller caps have higher returns. More shares for your money.

  7. leo says:

    why do you delete old events?

    • admin says:

      Hi Leo. The PDUFA calendar is set up so that all PDUFA/Advisory Committee dates are AUTOMATICALLY entered from information that I manually enter into the FDA Calendar. I made the decision to delete events from the FDA Calendar hoping to make it easier for investors to determine which events/catalysts were yet to occur and the FDA Calendar would no doubt become too full of unwanted information. This was primarily aimed at companies with upcoming clinical data releases or trial initiations. The FDA Calendar is primarily sorted by date with upcoming events at the top of the calendar to make it easier for investors to use. The downside to this is that past events are also removed from the PDUFA Calendar. In the previous version of the website (up until Dec ’11) previous PDUFA events were kept in the PDUFA Calendar, which was back then manually maintained. I’d like to keep the “automatic” updating feature of the PDUFA Calendar as it saves me much needed time, rather than “manually” updating it. I’m not sure if there’s a way around it but will investigate further.

      For your information, past PDUFA results are included in the Clinical Database.

  8. pat says:

    you are missing May 29th Cipher Pharms (DND.to) PDUFA date

  9. Stevo says:

    I noticed that the press release for DVAX for Feb “24” 2013 and you have it listed as “26”.

    Thanks for the calender.

    • admin says:


      Thanks very much for pointing the error out. It is much appreciated!

      I have fixed the error in both the FDA and PDUFA Calendars.

  10. Nick says:

    I believe you are missing EXEL’s cabo expecting a decision on November 30th.

    • admin says:


      I understand they sought priority review when they filed their NDA in May, which would result in a late Nov PDUFA date, but to my knowledge they haven’t heard back from the FDA. I haven’t seen it PR’d. Have you heard differently? I expect them to hear back from the FDA at the end of this month.

  11. Omar says:

    really appreciate your work amazing job, but i am new to this can you tell me where i to start reading about how to use this staff in good and correct way will be V.thankful

    really impressed

    • admin says:


      Sorry about the delay in getting back to you. The latest week has been very busy.

      There is no simple answer to your question unfortunately. In general terms, the aim is to identify a clinical catalyst and the likely result. If you’re new it’ll be easier to follow stocks with upcoming PDUFA dates and monitor the price behaviour leading up to the PDUFA date and action following the FDA decision.

  12. Anat says:

    You need to add HEB PDUFA in Feb.

  13. Tiran says:

    Great website!!
    CRTX recived approval on the 18/10 not 29/10.
    Can I have historical data since 2005?


  14. Upcoming BioPharma Catalyst Trades to Consider | StockMatusow.com says:

    […] FDA Decision is expected on November 30th for its supplemental New Drug Application (SNDA) to the US FDA for Promacta (eltrombopag) as a […]

  15. joe says:

    Best Site for Bio stocks!

  16. Name says:

    Great site!
    Many thanks.

  17. Nilesh Patel says:

    pdufa-calendar calendar seems to be broken. today.

    • admin says:

      Thanks for letting me know Nilesh. I will need to contact my webmaster regarding this as it seems to be quite a complex issue.

      Apologies for the inconvenience caused. Meanwhile, please refer to the FDA Calendar for PDUFA and Adcom dates.

    • admin says:

      Problem has been fixed. Should be working now. Thank you for your patience.

  18. Jamal Shirazi says:

    Great site,did you miss “DEPO” PDUFA date 0n 05/31/13 ,I read it somewhere,may be I am wrong.

  19. Jamal says:

    What do you think about AVEO approval chances on 07/28/13 ?

    • admin says:

      Very little chance of approval IMO. It’ll be the FDA Approval surprise of the decade if they get approval. They will have to conduct new trials and refile at a later date.

  20. Jamal says:

    I don’t see any PDUFA date for RMTI, they have successfully completed Phase 3 studies now,any idea on approval date?

  21. Jamal says:

    What are the Approval chances of DCTH and SGEN on 9/13/13 and 9/14/3,any comments?

  22. andre says:

    You might be missing a ADCOM and PDUFA for Lemtrada, Here is the news.

    FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will meet on Nov. 13-14 to discuss Lemtrada alemtuzumab from the Genzyme Corp. unit of Sanofi (Euronext:SAN; NYSE:SNY). The PDUFA date is in 4Q13, but the exact date is not disclosed. The European Commission approved Lemtrada last month.

    • admin says:

      Thanks Andre,

      I generally concentrate on small-mid cap companies so don’t follow large cap companies in detail. However, the Adcom event is definitely worth a listing so it has been put up. I have held off listing the PDUFA date as my calendar requires an exact date in order to be listed.



  23. andre says:

    It looks that the ADCOM for Northera on Jan 14, 2014 is missing.
    Here is the news:
    Chelsea Therapeutics International, Ltd. (CHTP) announced that the Cardiovascular and Renal Drug Advisory Committee of the U.S. Food and Drug Administration (:FDA) will review the New Drug Application (:NDA) filed for Northera in Jul 2013. The meeting is scheduled to take place on Jan 14, 2014.

  24. Jamal says:

    I think you are missing PDUFA date for GTHP, did you forget to put it or there is no date available?

  25. Han Neumann says:

    Do the FDA meetings for approvel and advisory mostly start at a specific time of the day, f.e. 10:00 am. ET ?

  26. Han Neumann says:

    That site doesn’t mention details like start ‘time of the day’. Maybe when signing up for updates on that site you get it. I will try to find out.

  27. Ray says:

    On May 26 2014 there is supposed to be a release. You do not show that date.

  28. lance says:

    sorry but why wasnt INSM in the calender for 17 of june fda approval

    • admin says:


      I think you might have misinterpreted today’s news. The FDA granted ARIKAYCE Breakthrough Therapy Designation only. This is NOT FDA Approval, though this undoubtedly gives INSM a better shot at receiving FDA Approval. The FDA does NOT set dates for Breakthrough Therapy Designation.

  29. lance says:

    Thank you so much for clearing my confusion. sorry that i misinterpreted the news.

  30. andre says:

    ITMN will have PDUFA date of Nov. 23, 2014 for Pirfenidone, a resubmitted Class 2 NDA.

  31. mike says:

    Please explain the difference between and ADCOM and a PDUFA date. Which comes first? Thanks much as the dates are often confusing..

    • admin says:


      The PDUFA date is the date when the FDA will make its approval decision for the drug concerned. They will either APPROVE it or issue a Complete Response Letter (non-approval letter).

      PRIOR to the PDUFA date an Advisory Committee (Adcom) meeting might be convened by the FDA. The FDA invites a group of so-called experts together with company representatives to lay out the reasons whether a drug should be approved or not. At the end of the meeting they vote whether to recommend approval or not.

      The FDA takes into account the Adcom vote when they make their final decision on the PDUFA date. Usually, they follow the vote given at the Adcom meeting, but they are not bound to do so.

      Hope that clears things up.

  32. andre says:

    I don’t know if you are already filling the calendar for 2015.
    KYTH just announced PDUFA date on May 13, 2013 for ATX-101 (deoxycholic acid).


  33. David says:

    Bio PDUFA calendar not coming through on my puter. Is there something wrong on your end?

  34. emory braswell says:

    I am new here so the answer maybe simple. I cannot see the PDUFA calendar on this page. Help?

  35. evaldas says:

    Maybe someone knows, where can find such great calender for Federal Energy Regulatory Commission (FERC) approval dates? Or there is no such calender? Please help. Thank you!

  36. Jamal says:

    You have not listed the PDUFA date for OXGN
    which is 11/19/14.

  37. Jamal says:

    My apologies,I was thinking about something else.
    you are right there is no PDUFA date for OXGN yet.

  38. Marsuculix says:

    Hi – thanks you for all the hard work making this excellent data available !
    Are you aware of the PDUFA of Vertex’s Kalydeco in cystic fibrosis on December 30 or am I wrong ?

    • admin says:


      Thank you for your question.
      I generally focus on small/mid cap firms only. VTRX is out of the range but will add it to the database.


  39. Yves says:

    Isn’t ADMP PDUFA mising?
    March 27 2015

  40. Antoine Cassagnol says:

    Mr. Burden,
    Thank you so much for the hard work you have put into putting this calendar together. I am very grateful for your work and hope to benefit from your information and you can share the rewards as a token of my appreciation.
    By the way, ACAD submitted their application on December 31, 2014. Is there a PDUFA date for their drug.
    Also, MDCO had a PDUFA date of Jan. 31, 2015. Have you heard anything since?
    Thank you again,

  41. Antoine says:

    Since I am new at this, can you please explain the timeline for the approval of a drug.
    I see PDUFA which is the final step. However, how about the NDA? what is it?
    There is also an advisory meeting set by the FDA, is it after the NDA has been submitted? What is the 60-day review? How long do companies have to wait to hear back from the FDA after they submitted their application?

    Can you please explain that process and the sequence of all these steps.

    PCRX obtained a negative response last week from the FDA and their stock went down, when will they resubmit again?

    Thank you so much for your time,

    • admin says:


      Thank you for your enquiry.

      In a nutshell, a NDA (New Drug Application) is when a company files their drug application for approval with the FDA.

      The FDA has about two months to consider whether to accept the filing, or not. This is the 60-day review. If it does accept the filing, and this happens 95% of the time, the FDA then issues a PDUFA date which will be in another 10 months. This date can be brought down to 6 months under a priority review. There are slightly different review periods for re-submissions following a CRL or a supplemental NDA filing for an already approved drug for a different indication.

      An advisory committee meeting is sometimes requested by the FDA. I would say this happens about 30% of the time. Please note this figure is right off the top of my head though! It might be lower/higher. If an Advisory Committee meeting is scheduled then this will be AFTER the NDA has been submitted but BEFORE the PDUFA date.

      Regarding, PCRX, I’m not sure if/when they will resubmit. I haven’t listened to their conference call and they just noted in their PR that they hope do schedule a End-of-Review meeting to discuss the CRL.

      Hope this helps.



  42. John says:


    Daniel, what can you tell me about Opko (OPK) and its dates with the FDA? Thanks so much. Nice work you do.

    • admin says:


      Rolapitant PDUFA is early September 2015.

      Rayaldee NDA filing is pending. It was due to be filed last quarter. Waiting for a company update.



  43. Sandy says:

    Sprout Pharmaceuticals had a FDA Advisory Panel for Flibanserin on June 5, 2015. The Panel gave a positive recommendation. Any idea on the actual PDUFA date?

    • admin says:


      PDUFA date for Flibanserin is August 18, 2015.
      Unfortunately, it can’t be listed on the BioPharmCatalyst PDUFA calendar as it is a non-listed company and a company stock ticker is required for the database.



  44. Arun says:


    Great job. I think it is a great resource.

    I wanted to know how do you forecast the price ( like 8.86 for BDSI ).

    Thank you.


    • admin says:

      Hi Arun,

      The price is actually the current price of the stock. However, I need to refresh it for it to appear on the website and that’s something I haven’t done for a while as the site hasn’t been updated since June. I will do a quick refresh now so the current price should now show.

  45. Sofie says:


    Would you kindly give me the exact date of ACADs NDA filing. Was the exact date September 3,2015 or was it a few days before that. Thank you kindly.

  46. Jeffrey Brummet says:

    Thankyou for the great service. Donating today.

    Please look at AGEN, press release for
    Jan. 21 are worth noting

    • admin says:


      Thank you for your message and donation.

      I looked into the press release you noted and also their latest earnings release earlier this month. I see that the trial concerned is a Phase 1 trial. Phase 1b (1/2), Phase 2 and Phase 3 trials only are tracked on BioPharmCatalyst, mainly due to the sheer volume of Phase 1 (1a) trials initiated. I will keep an eye on the noted trial to see if they progress through to Phase 2.



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