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
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
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
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
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
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
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
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
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