June 4, 2019.
Listed below are large cap, mid cap and small cap stocks with pending regulatory catalysts.FDA decision on Casimersen for DMD amenable to Exon 45 skippingFDA decision on Umbralisib as a treatment for for patients with previously treated marginal zone lymphomaFDA decision on trilaciclib for small cell lung cancer patients being treated with chemotherapyFDA decision on StrataGraft for the treatment of adult patients with deep partial-thickness thermal burns.FDA decision on GOCOVRI as a treatment for OFF episodes in Parkinson’s disease patients receiving levodopa-based therapyFDA decision on GOCOVRI as treatment for OFF episodes in Parkinson’s disease patients receiving levodopa-based therapyFDA decision on PRX–102 for the treatment of Fabry disease FDA decision on Voclosporin for the treatment of lupus nephritis FDA decision on Vericiguat in Patients with symptomatic chronic Heart Failure and Reduced Ejection FractionFDA decision on Tirbanibulin Ointment for the treatment of actinic keratosisFDA decision on FUROSCIX or the treatment of worsening heart failure due to congestionFDA decision on Arbaclofen ER for the treatment of spasticity in patients with MS FDA decision on MYL-1402O, a proposed biosimilar to AvastinFDA decision on Vibegron for the treatment of overactive bladder FDA decision on Roxadustat for the treatment of anemia of chronic kidney disease (CKD), in both non-dialysis-dependent and dialysis-dependent patients
Streamline your research and quickly compare the relative timing of competing catalysts. Recent New and Generic Drug Approvals. Find and follow all COVID-19 clinical trials. So having prior knowledge of the catalysts goes a long way toward maximizing profit or minimizing loss while trading volatile biotech stocks. Today's Medical Developments; June 2019; FDA Approvals Departments - Regulatory. COVID-19 Clinical Trial Tracker . Sign Up Log In. PDUFA dates and FDA Panel Review dates are very important because they are make or break events for biostocks when the decisions are announced.
This calendar tracks upcoming PDUFA drug approval dates and FDA advisory committee meetings.
Biotech Stock Catalyst and FDA Calendar for your biotech stock investing. New! Also, usually biostocks experience a run-up going into the scheduled decision/review dates. Enhanced FDA Calendar .
This report does not include BLAs/NDAs and supplements to those applications approved by CBER.
The U.S. Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) is a science-led organization in charge of overseeing the drug approval process before a drug is marketed.
For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA. PDUFA dates and FDA Panel Review dates are very important because they are make or break events for biostocks when the decisions are announced. CDER ensures that both brand and generic drugs work correctly and that the health benefits outweigh the known risks. Sign up or log in to access our Enhanced FDA Calendar! Also, usually biostocks experience a run-up going into the scheduled decision/review dates. Posted by Elizabeth Engler Modic Boston Scientific Corp. received approval for the Lotus Edge Aortic Valve System … Some approvals may be added to the Drugs@FDA database after this timespan. Biotech stocks with key binary events/catalysts - FDA Approval/PDUFA dates, Advisory Committee and Phase 2 & 3 trial data releases dates are noted.
This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. Subscribe . * Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products). Vir And Glaxo Start Phase 2/3 Trial For COVID-19 Antibody Treatment FDA Chief Apologizes For Remarks On COVID-19 Plasma Treatment Benefits FDA Grants Emergency Authorization For Blood Plasma To Treat Covid-19 Mass Testing In US Jails Identifies 12 Times More COVID Cases American Indians, Alaska Natives Who Tested Covid-19 Positive Tend To Be Younger By using this site, you agree to the
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