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
Alkermes plc
ALKS 5461 (NDA)
FDA’s final decision on ALKS 5461 for adjunctive treatment of major depressive disorder
Aquestive Therapeutics Inc.
APL-130277 (NDA)
FDA decision on APL-130277 to overcome episodic off periods in Parkinson's disease
Immunomedics Inc.
Sacituzumab govitecan (BLA)
FDA decision on Sacituzumab govitecan for treatment of metastatic triple-negative breast cancer
Amgen Inc.
EVENITY (Resubmission BLA)
FDA panel to review EVENITY for osteoporosis in postmenopausal women at high risk for fracture
Acorda Therapeutics Inc.
FDA decision on INBRIJA as a treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen.
Portola Pharmaceuticals Inc.
Andexxa Prior Approval Supplement
FDA decision on Andexxa for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed
Bristol-Myers Squibb Co.
Sprycel (sBLA)
FDA decision on Sprycel in combination with chemotherapy for pediatric patients with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia
Merck & Co Inc.
Keytruda (sBLA)
FDA decision on proposed new indication for Keytruda for recurrent locally advanced or metastatic Merkel cell carcinoma
Ocular Therapeutix Inc.
Dextenza (Resubmission NDA)
FDA decision on Dextenza for ocular pain following ophthalmic surgery
Bristol-Myers Squibb Co.
Empliciti (sBLA)
FDA decision on Empliciti in combination with pomalidomide and low-dose dexamethasone (EPd) for the treatment of patients with relapsed/refractory multiple myeloma
FDA approved Empliciti plus Pomalidomide and Dexamethasone for multiple myeloma on Nov.6, 2018
Roche Holding AG
Baloxavir Marboxil (NDA)
FDA decision on Baloxavir Marboxil for the treatment of acute, uncomplicated influenza in people 12 years and older
Shire plc
Prucalopride (NDA)
FDA decision on Prucalopride as a potential once-daily treatment option for chronic idiopathic constipation in adults
Jazz Pharmaceuticals plc
Solriamfetol (NDA)
FDA decision on Solriamfetol for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea
BIVIGAM (Prior Approval Supplement)
FDA decision on BIVIGAM, an intravenous immune globulin indicated for the treatment of primary humoral immunodeficiency
Roche Holding AG
FDA decision on TECENTRIQ in combination with Avastin or bevacizumab, paclitaxel and carboplatin or chemotherapy for initial treatment of people with metastatic NSCLC

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Medical marijuana dispensaries have opened for the first time in Iowa on Saturday, December 1, 2018. Five medical cannabidiol or CBD dispensaries have opened for business in Sioux City, Council Bluffs, Windsor Heights, Waterloo and Davenport. MedPharma Iowa, Iowa's only medical cannabidiol manufacturer, will manufacture all of the state's legal marijuana products in Des Moines.
The FDA is warning consumers about the risk of rare but serious cases of stroke and tears in the lining of arteries in the head and neck associated with multiple sclerosis drug Lemtrada, chemically known as Alemtuzumab. These problems can lead to permanent disability and even death.
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