• Mashup Score: 0
    FDA accepts NDA, sets PDUFA date for Ocuphire Pharma’s mydriasis treatment - 2 year(s) ago

    If approved later this year, phentolamine ophthalmic solution 0.75% could be the only commercially available eye drop for the reversal of dilation. It is being developed for reversal of pharmacologically-induced mydriasis, presbyopia, and dim light vision disturbances under the 505(b)(2) pathway.

    Source: Ophthalmology Times
    Categories: Latest Headlines, Ophthalmology
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      OphthTimes

      FDA accepts New Drug Application (NDA), sets PDUFA date for Ocuphire Pharma’s phentolamine ophthalmic solution 0.75% (Nyxol) for the treatment of pharmacologically-induced mydriasis (RM). Read more: https://t.co/OSUutPNPoM #PDUFA #FDA @US_FDA @ocuphire https://t.co/nNhkwbsSer

  • Mashup Score: 2
    Drug Development Dashboard - Friends of Cancer Research - 3 year(s) ago

    Friends has created a series of interactive dashboards as a tool to gain data driven insights into the landscape of oncology drug development and FDA drug approvals. The data in these dashboards are compiled from online publicly available data sources and are regularly updated. Dashboard Functionality Hover your mouse over the figures on the dashboards…

    Source: Friends of Cancer Research
    Categories: Hem/Onc News and Journals, Latest Headlines
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      CancerResrch

      98.4% of original #oncology approvals were approved on or ahead of their #PDUFA goal date, supporting timely and predictable access to new oncology #therapies. Explore #FriendsDashboard https://t.co/fvoj3kHjSc https://t.co/2A81OOppp0

  • Mashup Score: 0
    Drug Development Dashboard - Friends of Cancer Research - 3 year(s) ago

    Friends has created a series of interactive dashboards as a tool to gain data driven insights into the landscape of oncology drug development and FDA drug approvals. The data in these dashboards are compiled from online publicly available data sources and are regularly updated. Dashboard Functionality Hover your mouse over the figures on the dashboards…

    Source: Friends of Cancer Research
    Categories: Hem/Onc News and Journals, Latest Headlines
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    • Profile photo of CancerResrch
      CancerResrch

      98.4% of original #oncology approvals were approved on or ahead of their PDUFA goal date, indicating timelines established through #PDUFA help support timely and predictable access to new oncology #therapies. Explore #FriendsDashboard https://t.co/CWQX4YOxiq https://t.co/Dbel8ZncuS

  • Mashup Score: 0
    Will Major New FDA Law Include Accelerated Approvals Process? - 3 year(s) ago

    Advocates who have been calling for reforms in the accelerated approvals process are concerned that Congress may avoid this issue while finalizing a major FDA law.

    Source: Medscape
    Categories: Latest Headlines, Psychiatry
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      MedscapePsych

      Lawmakers are under pressure this month to decide whether to proceed with proposed reforms to the FDA accelerated approval pathway for medicines, including the need for speedier confirmatory trials. #PDUFA #FDALaw https://t.co/VWFzO8C7Q1

  • Mashup Score: 2
    Will Major New FDA Law Include Accelerated Approvals Process? - 3 year(s) ago

    Advocates who have been calling for reforms in the accelerated approvals process are concerned that Congress may avoid this issue while finalizing a major FDA law.

    Source: Medscape
    Categories: Hem/Onc News and Journals, Latest Headlines
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    • Profile photo of MedscapeOnc
      MedscapeOnc

      Lawmakers are under pressure this month to decide whether to proceed with proposed reforms to the FDA accelerated approval pathway for medicines, including the need for speedier confirmatory trials. #PDUFA #FDALaw #OncTwitter https://t.co/LSGZS6Bqwo

  • Mashup Score: 2
    Sign-On Letter: Urge the HELP Committee to include the RARE Act in FDASLA - 3 year(s) ago

    Right now, the Senate is debating the FDA Safety and Landmark Advancements Act (FDASLA), legislation that would reauthorize various user fee acts, including the Prescription Drug User Fee Act (PDUFA), which is of great importance to the rare disease community. Unfortunately, the current version of FDASLA does not include S. 4185, the Retaining Access and Restoring Exclusivity (RARE) Act, which is…

    Source: Google Docs
    Categories: Latest Headlines, Rare Disease
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    • Profile photo of RareDiseases
      RareDiseases

      Urgent Organization Level Sign-On Opportunity: Tell the Senate to Include the #RAREAct in #FDALSA Sign on: https://t.co/ZexXi4t7iU Note: This is an organization-level sign on letter, not an individual sign on letter. Deadline is 3pm ET on Friday, June 3. #PDUFA #RareDisease

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