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Of three accelerated approval drugs that have been ordered withdrawn to date, Pepaxto marks the shortest interval between the FDA drugs center's withdrawal proposal and the agency’s final order, suggesting that FDORA’s expedited withdrawal procedures helped move things along more quickly.

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Accelerated Approval: US FDA’s Hammer Falls On Oncopeptides’ Pepaxto

Rejecting company’s appeal, CBER Director Peter Marks says the multiple myeloma drug should be withdrawn because its confirmatory trial failed to verify clinical benefit and evidence demonstrates the drug is not safe and effective for its current indication.

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Lykos’ MDMA NDA Leads Upcoming Tests Of US FDA’s Psychedelics Draft Guidance

Pipeline is concentrated around Phase II, but sponsors have a few chances to see how FDA handles its ‘foundational constructs’ for psychedelic drugs, led by Lykos’ pending NDA for PTSD and Compass Pathways’ Phase III synthetic psilocybin COMP360 for treatment-resistant depression.

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For Psychedelics, US FDA Is Open To Creative Thinking But Firm On Approval Standards

Flexible thinking and rigorous standards will both be needed to develop psychedelics as drug therapies in order to surmount the many complicating factors, from unique ‘set and setting’ aspects to functional unblinding, speakers at Reagan-Udall Foundation meeting agree.

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Company Information

  • Industry
  • In Vitro Diagnostics
  • Medical Devices
  • Pharmaceuticals
  • Other Names / Subsidiaries
    • Abiomed, Inc.
    • Acclarent Inc.
    • Actelion Pharmaceuticals Ltd.
    • AdvanceCOR GmbH
    • ALZA Corporation
    • Alios BioPharma, Inc.
    • Animas Corporation
    • Aragon Pharmaceuticals, Inc.
    • Auris Health, Inc.
    • Auris Surgical Robotics
    • BeneVir Biopharm, Inc.
    • BioMedical Enterprises, Inc.
    • Biosense Webster, Inc.
    • Calibra Medical, Inc.
    • Centyrex Internal Venture
    • Cilag AG
    • Cerenovus
    • Codman & Shurtleff, Inc
    • Coherex Medical, Inc.
    • Conor Medsystems, Inc.
    • Cordis Webster, Inc.
    • CorImmun GmbH
    • Cougar Biotechnology, Inc.
    • Covagen AG
    • Crucell N.V.
    • DePuy Mitek, Inc.
    • DePuy Orthopaedics, Inc.
    • DePuy Synthes, Inc.
    • Ensure Medical
    • Ethicon, Inc.
    • FemRx Inc.
    • Flexible Stenting Solutions, Inc.
    • Gynecare, Inc.
    • Hansen Medical, Inc.
    • Innovative Surgical Solutions, LLC
    • Interventional Spine, Inc.
    • Janssen Biotech, Inc. (formerly Centocor Ortho Biotech Inc.)
    • Janssen Diagnostics
    • Janssen Pharmaceuticals
    • Janssen Vaccines & Prevention B.V.
    • JointPoint, Inc.
    • LifeScan, Inc.
    • Medical Enterprises Distribution, LLC
    • Medos International SARL
    • Megadyne Medical Products, Inc.
    • Mentor Corporation
    • Micrus Endovascular Corporation
    • Molsaic Internal Venture
    • Momenta Pharmaceuticals, Inc.
    • NeoStrata Company, Inc.
    • Neuravi Limited
    • NeuWave Medical, Inc.
    • Novira Therapeutics
    • Omrix Biopharmaceuticals, Inc.
    • Ortho Biotech Products, L.P.
    • Ortho-McNeil, Inc.
    • Orthotaxy
    • Peninsula Pharmaceuticals, Inc.
    • Pulsar Vascular Inc
    • RespiVert Ltd.
    • Scios, Inc.
    • Selected Nerve Stimulation Internal Ventures
    • Sentio, LLC
    • Sequus Pharmaceuticals
    • Stem Cell Internal Venture
    • Synthes, Inc.
    • Tibotec
    • Torax Medical, Inc.
    • Triage Medical, Inc.
    • Verb Surgical Inc.
    • Veridex
    • Vigor Sub, Inc.
    • Vistakon
    • XO1 Limited
    • TARIS Biomedical LLC
    • Verb Surgical, Inc.
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