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
GW Pharmaceuticals PLC
Epidiolex (NDA)
FDA decision on Epidiolex for treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome
Achaogen Inc.
Plazomicin (NDA)
FDA decision on Plazomicin for the treatment of complicated urinary tract infections, and bloodstream infections
scPharmaceuticals Inc.
Furoscix (505(b)(2) NDA)
FDA decision on Furoscix for treatment of worsening, or decompensated, heart failure outside of the inpatient setting
Dova Pharmaceuticals, Inc.
Avatrombopag (NDA)
FDA decision on Avatrombopag for the treatment of thrombocytopenia in patients with chronic liver disease
Amgen Inc.
Aimovig (BLA)
FDA decision on Aimovig for the prevention of migraine
Lipocine Inc
TLANDO (NDA resubmission)
FDA decision on TLANDO for the proposed indication of testosterone replacement therapy in adult males for hypogonadism
Seattle Genetics Inc.
FDA decision on expanded use of ADCETRIS for the frontline treatment of advanced classical Hodgkin lymphoma
Otonomy Inc.
FDA decision on OTIPRIO for acute otitis externa
Aerie Pharmaceuticals, Inc.
Rhopressa (NDA)
FDA decision on Rhopressa for the treatment of patients with open-angle glaucoma or ocular hypertension
FDA approved Rhopressa on Dec.18, 2017
La Jolla Pharmaceutical Co
LJPC-501 (angiotensin II) (NDA)
FDA decion on LJPC-501 or the treatment of hypotension in adults with distributive or vasodilatory shock
FDA approved Giapreza, formerly known as LJPC-501, on Dec.21, 2017
Roche Holding AG
Emicizumab (BLA)
FDA decision on Emicizumab for haemophilia A with inhibitors
FDA approved Hemlibra, previously known as Emicizumab, on Nov.16, 2017
Exelixis, Inc.
FDA decision on CABOMETYX as first-line monotherapy for advanced renal cell carcinoma
FDA approved CABOMETYX as first-line monotherapy on Dec.19, 2017.
AMAG Pharmaceuticals Inc.
Makena subcutaneous auto-injector (sNDA)
FDA decision on subcutaneous version of Makena to reduce the risk of preterm birth
Amgen Inc.
FDA decision to expand indication for XGEVA for prevention of skeletal-related events in patients with multiple myeloma
FDA approved XGEVA for prevention of skeletal-related events in patients with multiple myeloma on Jan.5, 2018.
Sucampo Pharmaceuticals Inc.
FDA decision on AMITIZA in children aged 6 to 17 years with pediatric functional constipation
Pharma-Fight012218.jpg Over the last decade alone, the U.S. healthcare system has saved $1.67 trillion due to the availability of low-cost generics, according to the 2017 Generic Drug Access and Savings Report. Even greater cost savings can be achieved if a more efficient generic drug review process is in place feels the FDA Commissioner Scott Gottlieb, and the regulatory agency is taking steps to achieve this goal.
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