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FDA Breakthrough Therapy
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FDA Approval
FDA Approves First-Of-Its-Kind Percep PC Neurostimulator with BrainSense Technology
Medtronic
PR-M06-20-NI-037-1471
Jun 26, 2020
FDA Breakthrough
Eiger Announces FDA Breakthrough Therapy Designation for Peginterferon Lambda for Treatment of Hepatitis Delta Virus Infection
Nice Insight
PR-M08-19-NI-071
Aug 26, 2019
Breakthrough Device Designation
FDA Grants Breakthrough Device Designation to Bio-Techne's ExoDx™ Prostate IntelliScore™ (EPI) Test
Bio-Techne Corporation
PR-M06-19-NI-029
Jun 19, 2019
FDA
FDA Grants Breakthrough Device Designation to Natera's Signatera Test
Natera
PR-M05-19-NI-025
May 08, 2019
FDA Designation
Array BioPharma Receives FDA Breakthrough Therapy Designation for BRAFTOVI™ in combination with MEKTOVI® and cetuximab for BRAFV600E-mutant Metastatic Colorectal Cancer
Array BioPharma
PR-M08-18-NI-070
Aug 16, 2018
Breakthrough Designation
Pfizer’s XALKORI® (crizotinib) Receives FDA Breakthrough Therapy Designation in Two New Indications
Pfizer
PR-M05-18-NI-113
May 30, 2018
FDA
Pfizer Granted FDA Breakthrough Therapy Designation for TRUMENBA®(Meningococcal Group B Vaccine)
Pfizer
PR-M04-18-NI-92
Apr 26, 2018
