FDA Calendar

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.

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Company Name
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
Roche Holding AG
Xofluza (sNDA)
FDA decision on Xofluza for post-exposure prophylaxis of influenza in people one year of age and older
Blueprint Medicines
Pralsetinib (NDA)
FDA decision on Pralsetinib for the treatment of locally advanced or metastatic RET fusion-positive NSCLC
Eiger BioPharmaceuticals Inc.
Zokinvy (NDA)
FDA decision on Zokinvy (lonafarnib) for treatment of Progeria and Progeroid Laminopathies
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
Alkermes plc
ALKS 3831 (NDA)
FDA decision on ALKS 3831 for the treatment of schizophrenia and for the treatment of bipolar I disorder
Amgen Inc.
FDA decision on KYPROLIS in combination with dexamethasone and DARZALEX® (daratumumab) for patients with relapsed or refractory multiple myeloma
Sutimlimab (BLA)
FDA decision on Sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease
Supernus Pharmaceuticals, Inc.
SPN-812 (NDA)
FDA decision on SPN-812 for the treatment of ADHD
Kala Pharmaceuticals, Inc.
EYSUVIS 0.25% (Resubmitted NDA)
FDA decision on EYSUVIS 0.25% for Dry Eye Disease
Regeneron Pharmaceuticals
FDA decision on REGN-EB3 for Ebola virus infection
Spectrum Pharmaceuticals Inc
FDA decision on ROLONTIS for the treatment of chemotherapy-induced neutropenia
Zosano Pharma Corporation
Qtrypta (NDA)
FDA decision on Qtrypta for the acute treatment of Migraine
Halozyme Therapeutics, Inc.
Perjeta And Herceptin Using Enhanze Technology (BLA)
FDA decision on subcutaneous combination of Perjeta and Herceptin Using Enhanze Technology for breast cancer
Roche Holding AG
Perjeta and Herceptin.Using Enhanze Technology (BLA)
FDA decision on subcutaneous combination of Perjeta and Herceptin Using Enhanze Technology for breast cancer
FDA approved Phesgo (Perjeta and Herceptin) on July 29, 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.

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