The FDA calendar tracks upcoming PDUFA drug approval dates, FDA Advisory Committee meetings, and trading notes. Click on the Categories drop down on the top left side of the calendar to turn PDUFA, FDA Advisory Committee (Adcom), and trade notes, either on or off. Each overlay toggles between on and off when it is clicked. If you unselect all overlays, you will see the default view which is all calendar events.

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You can click on an event pop-up to go to an individual event details page that includes a source link, most likely a company press release, presentation or SEC filing. Sometimes companies remove links from their websites which might result in the source not being available.

Finally, you can search the entire FDA calendar by using the search box below.

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MRK Keytruda
MRK Keytruda
Apr 3 all-day
MRK Keytruda
(MRK) Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma (PMBCL). PDUFA date for sBLA April 3, 2018.
THERF Ibalizumab
THERF Ibalizumab
Apr 3 all-day
THERF Ibalizumab
(THERF) Multi-drug resistant HIV-1. Original PDUFA date January 3, 2018 extended 3 months to April 3. 2018.
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CLVS Rucaparib ARIEL3
CLVS Rucaparib ARIEL3
Apr 6 all-day
CLVS Rucaparib ARIEL3
(CLVS) Ovarian cancer patients with a BRCA-like mutation. Phase 3 data released June 20 2017, primary endpoint met. PDUFA date under priority review April 6, 2018.
PCRX EXPAREL
PCRX EXPAREL
Apr 6 all-day
PCRX EXPAREL
(PCRX) Phase 3 data released July 25, 2017. Upper extremity met primary endpoint, lower extremity trial missed endpoint. PDUFA date for sNDA filing set for April 6, 2018. http://investor.pacira.com/phoenix.zhtml?c=220759&p=irol-newsArticle&ID=2316759
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LLY Abemaciclib – MONARCH 3
LLY Abemaciclib – MONARCH 3
Apr 12 all-day
LLY Abemaciclib - MONARCH 3
(LLY) Phase 3 data release on April 24, 2017, met primary endpoint. Priority review granted October 12, 2017. Priority review usually takes 6 months so 6 months from October 12, 2017 is April 12, 2018.
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BMY CM-214 โ€“ Opdivo with Yervoy
BMY CM-214 โ€“ Opdivo with Yervoy
Apr 16 all-day
BMY CM-214 โ€“ Opdivo with Yervoy
(BMY) First-line Renal cell carcinoma. Phase 3 trial stopped early due to clear efficacy, trial met co-primary endpoint. PDUFA under priority review April 16, 2018.
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RARE KRN23 Burosumab
RARE KRN23 Burosumab
Apr 17 all-day
RARE KRN23 Burosumab
(RARE) X-Linked Hypophosphatemia. Phase 3 data released April 18, 2017, met primary endpoint. PDUFA date under priority review April 17, 2018.
RIGL Fostamatinib
RIGL Fostamatinib
Apr 17 all-day
RIGL Fostamatinib
(RIGL) Immune Thrombocytopenic Purpura. Phase 3 data from the first trial released August 30 2016. Primary endpoint met. Data from second trial did not meet the primary endpoint. PDUFA date April 17, 2018. With the Read More ยป
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NBIX Elagolix
NBIX Elagolix
Apr 27 all-day
NBIX Elagolix
(NBIX) Endometriosis. First Phase 3 trials met endpoints. NDA filing announced September 6, 2017. Priority review announced October 27, 2017. April 27, 2017 based on 6-month review time.
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MNK Lubiprostone
MNK Lubiprostone
Apr 28 all-day
MNK Lubiprostone
(MNK) Pediatric functional constipation. PDUFA date for sNDA under priority review extended by three months to April 28, 2018. https://ir.sucampo.com/all-sec-filings/content/0001193125-18-000287/d515718d8k.htm?TB_iframe=true&height=auto&width=auto&preload=false
SCMP Lubiprostone
SCMP Lubiprostone
Apr 28 all-day
SCMP Lubiprostone
(SCMP) Pediatric functional constipation. PDUFA date for sNDA under priority review extended by three months to April 28, 2018.
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AMGN KYPROLIS (ENDEAVOR)
AMGN KYPROLIS (ENDEAVOR)
Apr 30 all-day
AMGN KYPROLIS (ENDEAVOR)
(AMGN) Relapsed Multiple Myeloma. Phase 3 trial met endpoints. PDUFA date for sNDA April 30, 2018.
NVS Kymriah (CTL019 )- JULIET
NVS Kymriah (CTL019 )- JULIET
Apr 30 all-day
NVS Kymriah (CTL019 )- JULIET
(NVS) Cancer – Diffuse Large B-Cell Lymphoma. sBLA filing announced October 31, 2017. No PDUFA date given. Estimate April 30, 2018 using 6 month priority review timeframe following receipt of sBLA by FDA.
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