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.

To change the view of the calendar, click on the Month drop down on the top right side of the calendar. You can choose from 6 different views of the calendar depending on what you are studying and your own preference. Posterboard is a popular view, check it out.

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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Sun Mon Tue Wed Thu Fri Sat
1
ATRS Stalking
ATRS Stalking
Feb 1 all-day
ATRS Stalking
Stalk (ATRS). Most traders playing (AMAG) but could have forgotten about ATRS for the February 14, 2018 PDUFA. Did this research report on ATRS here.
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VRTX Setup Looking Compelling
VRTX Setup Looking Compelling
Feb 11 all-day
VRTX Setup Looking Compelling
(VRTX) setup on the chart looking good ahead of February 28, 2018. Have not done research on VRTX but with general market pullback, the stock has not run up ahead of its February 28, 2018 … Continue reading "VRTX Setup Looking Compelling"
12
CLVS Juicy Setup
CLVS Juicy Setup
Feb 12 all-day
CLVS Juicy Setup
(CLVS) Juicy looking setup ahead of April 6, 2018 PDUFA. With larger market sell-off due to short volatility unwind, lots of biotech firms are compelling setups ahead of their PDUFAs.
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AMAG ATRS Makena – auto injector
AMAG ATRS Makena – auto injector
Feb 14 all-day
AMAG ATRS Makena - auto injector
(AMAG) (ATRS) Reduce the risk of preterm birth in women with a singleton pregnancy. sNDA filing announced April 17, 2017. PDUFA date February 14, 2018. 10-month review despite initial expectations of a 6-month review. http://ir.amagpharma.com/phoenix.zhtml?c=61596&p=irol-newsArticle&ID=2283026
PCRX EXPAREL
PCRX EXPAREL
Feb 14 – Feb 15 all-day
PCRX EXPAREL
(PCRX) Phase 3 data released July 25, 2017. Upper extremity met primary endpoint, lower extremity trial missed endpoint. Advisory Committee Meeting February 14-15, 2018. http://investor.pacira.com/phoenix.zhtml?c=220759&p=irol-newsArticle&ID=2316759
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SCPH Pump on Seeking Alpha
SCPH Pump on Seeking Alpha
Feb 16 all-day
SCPH Pump on Seeking Alpha
Regarding PDUFA event for (SCPH) on June 23, 2018, pump on Seeking Alpha where author Jonathan Faison mentions some important points but leaves out the most important point of all: the Phase 3 trial of … Continue reading "SCPH Pump on Seeking Alpha"
VRTX Killer Setup IMO
VRTX Killer Setup IMO
Feb 16 all-day
VRTX Killer Setup IMO
(VRTX) has formed a killer candle over candle bounce on the chart. Liking the setup going into the PDUFA later this month.
17
APRI Vitaros
APRI Vitaros
Feb 17 all-day
APRI Vitaros
(APRI) Erectile dysfunction. PDUFA date for NDA resubmission February 17, 2018. http://ir.apricusbio.com/phoenix.zhtml?c=118007&p=irol-newsArticle&ID=2297639
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KMPH KP201/APAP
KMPH KP201/APAP
Feb 23 all-day
KMPH KP201/APAP
(KMPH) Acute pain. PDUFA date February 23, 2018 – CRL issued June 13, 2016. http://investors.kempharm.com/phoenix.zhtml?c=253970&p=irol-newsArticle&ID=2299948
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SRNE ZTlido (lidocaine patch 1.8%)
SRNE ZTlido (lidocaine patch 1.8%)
Feb 28 all-day
SRNE ZTlido (lidocaine patch 1.8%)
(SRNE) Pain associated with post-herpetic neuralgia (PHN). PDUFA date for NDA resubmission February 28, 2017. http://sorrentotherapeutics.com/news__trashed/news-display/?id=122635
VRTX Tezacaftor (VX-661) / ivacaftor
VRTX Tezacaftor (VX-661) / ivacaftor
Feb 28 all-day
VRTX Tezacaftor (VX-661) / ivacaftor
(VRTX) Cystic fibrosis – Two Copies of the F508del Mutation. Phase 3 data released March 28, 2017 – primary endpoint met. PDUFA date under priority review February 28, 2017. http://investors.vrtx.com/releasedetail.cfm?ReleaseID=1038173
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