logo

FDA Calendar

Share
PDUFA dates and FDA Panel Review dates are very important because they are make or break events for biostocks when the decisions are announced. Also, usually biostocks experience a run-up going into the scheduled decision/review dates. So having prior knowledge of the catalysts goes a long way toward maximizing profit or minimizing loss while trading volatile biotech stocks.
Listed below are large cap, mid cap and small cap stocks with pending regulatory catalysts.

Get in-depth analysis and insight on investing in the high-stakes biotech and pharma sectors. Check out our premium biotech research product and our biotech home page.
Company Name
Ticker
Drug
Event
Date
Outcome
Details
Revance Therapeutics, Inc.
DAXI (BLA)
FDA decision on DAXI in the treatment of moderate to severe glabellar (frown) lines
11/25/2020
Liquidia Technologies Inc.
LIQ861 (NDA)
FDA decision on LIQ861 for the treatment of pulmonary arterial hypertension
11/24/2020
Roche Holding AG
Nnew formulation of Xofluza (NDA)
FDA decision on Xofluza for the treatment of acute uncomplicated influenza in otherwise healthy children aged one to less than 12 years of age who have been symptomatic for no more than 48 hours
11/23/2020
Roche Holding AG
New formulation of Xofluza as one-dose granules for oral suspension (NDA)
FDA decision on new formulation of Xofluza treat the flu (influenza) in people 12 years of age and older
11/23/2020
Roche Holding AG
Xofluza (sNDA)
FDA decision on Xofluza for treatment of acute uncomplicated influenza in otherwise healthy children aged one to less than 12 years of age who have been symptomatic for no more than 48 hour
11/23/2020
Roche Holding AG
Xofluza (sNDA)
FDA decision on Xofluza for post-exposure prophylaxis of influenza in people one year of age and older
11/23/2020
Bristol-Myers Squibb Co.
Lisocabtagene maraleucel (BLA)
FDA decision on Lisocabtagene maraleucel for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies
11/16/2020
Alkermes plc
ALKS 3831 (NDA)
FDA decision on ALKS 3831 for the treatment of schizophrenia and for the treatment of bipolar I disorder
11/15/2020
Amgen Inc.
KYPROLIS (sNDA)
FDA decision on KYPROLIS in combination with dexamethasone and DARZALEX® (daratumumab) for patients with relapsed or refractory multiple myeloma
11/15/2020
Sanofi
Sutimlimab (BLA)
FDA decision on Sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease
11/13/2020
Supernus Pharmaceuticals, Inc.
SPN-812 (NDA)
FDA decision on SPN-812 for the treatment of ADHD
11/08/2020
Kala Pharmaceuticals, Inc.
EYSUVIS 0.25% (Resubmission NDA)
FDA decision on EYSUVIS 0.25% for Dry Eye Disease
10/30/2020
Regeneron Pharmaceuticals
REGN-EB3 (BLA)
FDA decision on REGN-EB3 for Ebola virus infection
10/25/2020
Spectrum Pharmaceuticals Inc
ROLONTIS (BLA)
FDA decision on ROLONTIS for the treatment of chemotherapy-induced neutropenia
10/24/2020
Zosano Pharma Corporation
Qtrypta (NDA)
FDA decision on Qtrypta for the acute treatment of Migraine
10/20/2020

ALSO READ - COVID-19 Drugs In Development Calendar which lists Companies that are in Race to find a Treatment or Vaccine for the Novel Coronavirus.

Buy this Content


covid19 may29 The week that just passed by saw some big names joining the race to develop vaccines for COVID-19, a couple of deals to speed up the manufacture of the vaccine and promising trial results of one of the potential COVID-19 treatments.
investing biotech 042420 29may20 Here's a quick look at some of today's ASCO presentations.
logos may30 Today's Daily Dose brings you news about ARCA biopharma joining the battle against COVID-19; Genmab's positive results from amyloidosis trial; MacroGenics' regulatory update related to breast cancer drug candidate Margetuximab and Simulations Plus receiving the FDA grant award.
Read More
After a week's lull in the number of people getting infected from coronavirus in the United States, the daily infection rate has climbed back to above 20,000. With 23051 new cases reporting in the last 24 hours, the total number of infections in the country rose to 1,721,926 as of John Hopkins University's 6:00 a.m. ET update Friday.This is 4374 more cases than what was reported in the previous d
The number of coronavirus deaths in the United States has topped the 100,000 mark nearly hundred days after the first COVID-19 infection in the country was reported in Washington. The death toll is around as many Americans who died from Covid-19 as from the accumulated number of US troops killed in Korea, Vietnam, Iraq and Afghanistan wars over decades. In a reverse trend, new coronavir
Cresco Labs Inc., a multi-state cannabis operator, said it has entered into agreements with Verdant Creations, LLC that will provide it the option to purchase four additional medical marijuana dispensaries in Ohio currently operated by Verdant. Cresco will pay $375,000 in cash and $500,000 of its...
Read More