FDA Approval
FDA Approves First-Of-Its-Kind Percep PC Neurostimulator with BrainSense Technology
Medtronic
PR-M06-20-NI-037-1471Jun 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-071Aug 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-029Jun 19, 2019
FDA
FDA Grants Breakthrough Device Designation to Natera's Signatera Test
Natera
PR-M05-19-NI-025May 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-070Aug 16, 2018
Breakthrough Designation
Pfizer’s XALKORI® (crizotinib) Receives FDA Breakthrough Therapy Designation in Two New Indications
Pfizer
PR-M05-18-NI-113May 30, 2018
FDA
Pfizer Granted FDA Breakthrough Therapy Designation for TRUMENBA®(Meningococcal Group B Vaccine)
Pfizer
PR-M04-18-NI-92Apr 26, 2018