fda

  1. G

    FDA Accepts Filing of ALS Drug EdaravonE

    I noted this ~3 months back, but it got more press. The FDA has accepted the New Drug Application (NDA) for edaravone (MCI-186) to treat amyotrophic lateral sclerosis (ALS). The PDUFA date — the day when a decision on the application is expected — is June 16, 2017. FDA Accepts Filing of ALS...
  2. G

    Getting drugs released prior to trials

    Have been following AB Science and their drug Masitinib. Just noticed today on their press release that the FDA are, and have , released this drug for compassionate use in ALS prior to clinical trials. Is this new? First time I have seen it and obviously that's exciting . Is it not time we all...
  3. B

    What and when ?

    I'm almost two years into my nightmare, and every day I check a half dozen or so ALS websites to see what's new. And every day there is something new. Most of the new stuff falls under the heading of basic research. I'm not expecting to read that a cure has been found. That's not realistic...
  4. P

    LTMV via NIV

    Long Term Mechanical Ventilation with Non-Invasive Ventilation I have been using this eye gaze for a few months. I have not been able to copy small pertinent sections form articles. Anybody that can, please do, and add anything that might clarify. If I am misunderstanding these papers, I am...
  5. G

    FDA-approved anti-epileptic drug perampanel is able to prevent the progression of ALS

    For sporadic ALS. Experimental results showed the drug was able to prevent the death of motor neurons and normalized the localization of TDP-43 with the cells. Moreover, long-term administration of the drug in mice also led to visible improvement of motor dysfunction in the treated mice, as...
  6. lgelb

    Draft FDA Guidance Document

    Just a reminder that public comments on this document are due by the 30th. And a side note: for those of you hunting prognostic markers/measures, a number are mentioned in recommending possible outcome measures for clinical trials. Not all of them are based on equally good data, but they may...
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    VM BioPharma's VM202 granted fast track

    The U.S. Food and Drug Administration (FDA) has given Fast Track designation to VM BioPharma’s lead investigational drug candidate, VM202, a potential gene therapy for the treatment of amyotrophic lateral sclerosis (ALS). Link here...
  8. D

    Masitinib phase 3 !

    PARIS, April 4, 2016 -- AB Science Announces Positive Interim Results from Phase 3 Trial of Masitinib in Amyotrophic Lateral Sclerosis (ALS) (also known as Lou Gehrig's disease) Company to Host Webcast on Masitinib in ALS in the Coming Days AB Science SA (NYSE Euronext - FR0010557264 - AB), a...
    • DrFab
    • Thread
    • als atrophy brain clinical clinical study data death disability fda fvc lou gehrig's disease media medical medicine milestone muscles neurology paralysis progression research respiratory riluzole sensitivity symptoms treatment trial tyrosine
    • Replies: 2
    • Forum: Research and trials
  9. A

    Endogenous retorvirus and HIV drugs

    I have heard of a trial that is going to test a combination of drugs currently used to treat HIV on patients with ALS. These drugs are supposed to reduce retroviral activity. I think the drugs are going to be tested on people that do show such activity on a test. I was interested in the trial...
  10. P

    PoNS: Heard of it!

    Portable neurological stimulator, PoNS. Non-invasive! Developed by University of Wisconsin-Madison. Marketing will be done by Helius Medical Technologies. FDA approval should be in 2016. Researcher told me over the phone that he knows it will help all neurological disorders just have to...
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