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
Amgen Inc.
Aimovig (BLA)
FDA decision on Aimovig for the prevention of migraine
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
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
AMAG Pharmaceuticals Inc.
Makena subcutaneous auto-injector (sNDA)
FDA decision on subcutaneous version of Makena to reduce the risk of preterm birth
Synergy Pharmaceuticals, Inc.
FDA decision on TRULANCE for the treatment of adults with irritable bowel syndrome with constipation
Ligand Pharmaceuticals Inc
FDA decision on LUXTURNA for inherited retinal disease
Spark Therapeutics
FDA decision on LUXTURNA for treatment of patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy.
Eli Lilly And Co.
Abemaciclib (NDA)
FDA decision on Abemaciclib for the treatment of advanced breast cancer
Intersect ENT Inc
SINUVA implant (NDA)
FDA decision on SINUVA implant for patients with recurrent ethmoid sinus obstruction
AEterna Zentaris Inc
Macrilen (NDA resubmission)
FDA decision on Macrilen for the evaluation of growth hormone deficiency in adults
Valeant Pharmaceuticals International
Luminesse (NDA)
FDA decision on Luminesse to be used Over-the-Counter as an eye drop to relieve redness of the eye due to minor eye irritations.
Roche Holding AG
Gazyva (sBLA)
FDA decion on Gazyva for people with previously untreated follicular lymphoma
FDA approved Gazyva for previously untreated advanced follicular lymphoma on Nov.16, 2017
Novo Nordisk A/S
Semaglutide (NDA)
FDA decision on Semaglutide to improve glycemic control in adults with type 2 diabetes.
Mylan N.V.
MYL-1401O (BLA)
FDA decision on MYL-1401O as a proposed biosimilar to Roche's Herceptin
Pharma-111717.jpg Today's Daily Dose brings you news about Aerie's progress in phase II trial of glaucoma drug in Japan; phase III results of Egalet's pain pill; FDA approval of GlaxoSmithKline's COPD drug; expanded labeling for Pfizer's kidney cancer drug Sutent and Roche's double blessing on Thursday.
pharma-111617.jpg Today's Daily Dose brings you news about FDA approval of Faslodex-Verzenio combo for advanced breast cancer; EDAP's disappointing Q3 results; upcoming clinical trial catalysts of TapImmune, and the first drug to be greenlighted for Sly syndrome.
Pharma-111517.jpg Today's Daily Dose brings you news about Apollo Medical's fiscal 2018 second quarter financial results; FDA approval of AstraZeneca's asthma drug; EyeGate's upcoming clinical trial catalysts; Genmab's revised revenue outlook and Pacira's update on its EXPAREL sNDA.
Billionaire and Microsoft co-founder Bill Gates is making a personal investment of $50 million into the Dementia Discovery Fund, a venture capital fund that invests in projects and companies to develop treatments for the brain-wasting disease. The investment is not part of Gates' philanthropic Bill & Melinda Gates Foundation, which has focused primarily on infectious diseases.
Bristol-Myers Squibb Co. (BMY) announced the U.S. Food and Drug Administration (FDA) has expanded the indication for Sprycel or dasatinib tablets to include the treatment of children with Philadelphia chromosome-positive or Ph+ chronic myeloid leukemia or CML in chronic phase or CP. The approval for...
Yet another month has gone by, and it's time again to take a look-back at the new drugs that successfully crossed the therapeutics finish line. At the time of writing, 37 novel drugs were approved by the FDA for this year. This compares favorably with 22 novel drugs that were approved for the whole of 2016. Click here for the list of new drugs approved in October.
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