Cognitive Impairment

• FDA approval · 2020-01-10
  FDA Approved: VIZAMYL — Supplemental Application (GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare))

  FDA approved a supplemental application for Vizamyl (flutemetamol F-18) from GE Healthcare, expanding its regulatory authorization to includ…

• FDA approval · 2020-01-10
  FDA Approved: NEURACEQ — Supplemental Application (Lantheus Biosciences Ltd.)

  FDA approved a supplemental application for NEURACEQ (florbetaben F-18) from Lantheus Biosciences Ltd., granting continued approval for its …

• FDA approval · 2018-07-10
  FDA Approved: NEURACEQ — Supplemental Application (Lantheus Biosciences Ltd.)

  FDA approved a supplemental application for NEURACEQ (Florbetaben F-18) from Lantheus Biosciences Ltd.

• FDA approval · 2017-02-22
  FDA Approved: VIZAMYL — Supplemental Application (GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare))

  FDA approved a supplemental application for Vizamyl (flutemetamol F-18) submitted by GE Healthcare Inc. The action updates the regulatory st…

• FDA approval · 2016-01-25
  FDA Approved: NEURACEQ — Supplemental Application (Lantheus Biosciences Ltd.)

  FDA approved a supplemental application for NEURACEQ (Florbetaben F-18) by Lantheus Biosciences Ltd., supporting its use as a PET imaging ag…

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• FDA approval · 2015-05-18
  FDA Approved: NEURACEQ — Supplemental Application (Lantheus Biosciences Ltd.)

  The FDA approved a supplemental application for NEURACEQ (FLORBETABEN F 18) submitted by Lantheus Biosciences Ltd.

• FDA approval · 2014-03-19
  FDA Approved: NEURACEQ — Original Application (Lantheus Biosciences Ltd.)

  FDA approved NEURACEQ (florbetaben F-18) for PET imaging to estimate beta-amyloid neuritic plaque density in adults with cognitive impairmen…