FDA grants orphan drug designation to AmideBio for treatment of congenital hyperinsulinism

FDA grants orphan drug designation to AmideBio for treatment of congenital hyperinsulinism

BOULDER -- AmideBioLLC , a privately held biopharmaceutical company, announced that the U.S. Food and Drug Administration Office of Orphan Products Development granted an orphan drug designation to... Read More

Friday April 24, 2020 0 comments Tags: Boulder, Amedebio, Pawel Fludzinski, FDA

FDA expedites approval of Cochlear's Remote Check for cochlear implants

FDA expedites approval of Cochlear's Remote Check for cochlear implants

CENTENNIAL -- Cochlear Limited (ASX: COH), a leader in implantable hearing solutions, announced it has obtained U.S. Food and Drug Administration (FDA) approval for its Remote Check solution. The... Read More

Thursday April 9, 2020 0 comments Tags: Centennial, Cochlear Limited, Remote Check, FDA, COVID-19, Tony Manna

Ampio Pharmaceutical's FDA application for Ampion clinical study to treat COVID-19 ARDS on TV

Ampio Pharmaceutical's FDA application for Ampion clinical study to treat COVID-19 ARDS on TV

ENGLEWOOD -- Ampio Pharmaceuticals, Inc . (NYSE American: AMPE) announced it was featured on aFOXTV segment titled, "Englewoodpharmaceutical company looking to treat COVID-19 patients with... Read More

Friday April 3, 2020 0 comments Tags: Englewood, Ampio Pharmaceuticals, Ampion, Michael Macaluso, FDA, COVID-19, ARDS

ArcherDX Personalized Cancer Monitoring (PCM) tech designated by FDA as Breakthrough Device

ArcherDX Personalized Cancer Monitoring (PCM) tech designated by FDA as Breakthrough Device

BOULDER -- ArcherDX, Inc. announced it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Personalized Cancer Monitoring (PCM) technology, a... Read More

Wednesday January 15, 2020 0 comments Tags: Boulder, ArcherDx, Jason Myers, FDA

Oxalert EPO wearable device granted FDA Breakthrough Status

Oxalert EPO wearable device granted FDA Breakthrough Status

COLORADO SPRINGS -- The FDA has granted Breakthrough Device status to Med-botics, LLC for its Oxalert EPO TM (Enhanced Pulse Oximeter) device. The wrist-worn arousal device is designed to... Read More

Wednesday October 30, 2019 0 comments Tags: Colorado Springs, Med-botics, FDA, Oxalert EPO, Richard Dutton

Cochlear: FDA approves new Nucleus Profile Plus implant series with Android smartphone connectivity

Cochlear: FDA approves new Nucleus Profile Plus implant series with Android smartphone connectivity

CENTENNIAL -- Cochlear Limited ( ASX: COH), a global leader in implantable hearing solutions, today announced the U.S. Food and Drug Administration's approval of the new Cochlear Nucleus ... Read More

Monday June 17, 2019 0 comments Tags: Centennial, Cochlear Limited, Nucleus Profile Plus Implant, Tony Manna, Patricia Troutwein, FDA

Clovis Oncology receives Breakthrough Therapy designation for Rubraca

Clovis Oncology receives Breakthrough Therapy designation for Rubraca

BOULDER -- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced theU.S. Food and Drug Administration(FDA) has granted Breakthrough Therapy designation for Rubraca (rucaparib) as a monotherapy... Read More

Tuesday October 2, 2018 0 comments Tags: Boulder, Clovis Oncology, Rubraca, Patrick J. Mahaffy, FDA

Array BioPharma colorectal cancer drugs receive Breakthrough Therapy Designation from FDA

Array BioPharma colorectal cancer drugs receive Breakthrough Therapy Designation from FDA

BOULDER -- Array BioPharma Inc. (NASDAQ: ARRY) today announced it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for encorafenib (BRAFTOVI),... Read More

Tuesday August 7, 2018 0 comments Tags: Boulder, Array BioPharma, Victor Sandor, FDA