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FDA Breakthrough Therapy

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Medtronic
FDA Approval

FDA Approves First-Of-Its-Kind Percep PC Neurostimulator with BrainSense Technology

Medtronic

PR-M06-20-NI-037-1471Jun 26, 2020
Eiger Announces FDA Breakthrough Therapy Designation for Peginterferon Lambda for Treatment of Hepatitis Delta Virus Infection
FDA Breakthrough

Eiger Announces FDA Breakthrough Therapy Designation for Peginterferon Lambda for Treatment of Hepatitis Delta Virus Infection

Nice Insight

PR-M08-19-NI-071Aug 26, 2019
Bio-Techne Corporation
Breakthrough Device Designation

FDA Grants Breakthrough Device Designation to Bio-Techne's ExoDx™ Prostate IntelliScore™ (EPI) Test

Bio-Techne Corporation

PR-M06-19-NI-029Jun 19, 2019
Natera
FDA

FDA Grants Breakthrough Device Designation to Natera's Signatera Test

Natera

PR-M05-19-NI-025May 08, 2019
Array BioPharma
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-070Aug 16, 2018
Pfizer
Breakthrough Designation

Pfizer’s XALKORI® (crizotinib) Receives FDA Breakthrough Therapy Designation in Two New Indications

Pfizer

PR-M05-18-NI-113May 30, 2018
Pfizer
FDA

Pfizer Granted FDA Breakthrough Therapy Designation for TRUMENBA®(Meningococcal Group B Vaccine)

Pfizer

PR-M04-18-NI-92Apr 26, 2018
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