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Rezafungin Review Highlights US FDA’s ‘Flexible Development' Approach For Antimicrobials

Cidara developed the antifungal for candidemia/invasive candidiasis pursuant to the FDA’s 2017 ‘Unmet Need guidance,’ which provides an avenue for approval with a 'limited use' indication based on a streamlined development program. Some of the guidance recommendations also have been leveraged under the LPAD pathway.

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Some sponsors appear to be growing antsy to meet with agency staff and advisory committees in-person, but CDER continues to schedule only virtual meetings.

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Company Information

  • Industry
  • Pharmaceuticals
  • Pharmaceuticals
    • Specialty Pharmaceuticals
    • Vaccines
  • Other Names / Subsidiaries
    • Ablynx N.V.
    • Acambis PLC
    • Avigen Inc.
    • Bioverativ Inc. (True North Therapeutics, Inc.)
    • BiPar Sciences Inc.
    • BMP Sunstone Corporation
    • Canderm Pharma Inc.
    • Celmed BioSciences, Inc.
    • Chattem, Inc.
    • Connaught Laboratories Ltd.
    • Fisons Ltd.
    • Fovea Pharmaceuticals, SA
    • Genfar S.A.
    • Genzyme Corporation
    • Groupe Sanofi
    • Hoechst Marion Roussel
    • Kadmon Holdings, Inc.
    • Kiadis Pharma B.V.
    • Kiadis Pharma N.V.
    • Pluromed
    • Principia Biopharma Inc. Protein Sciences Corporation
    • Rhone-Poulenc Rorer
    • Sanofi-Aventis
    • Sanofi-aventis Groupe
    • Sanofi Pasteur MSD
    • Shantha
    • Synthorx, Inc. (THOR)
    • TargeGen, Inc.
    • Thunder Acquisition
    • Tidal Therapeutics
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