Cytocom receives FDA clearance of IND for Phase 2 clinical trial of CYTO-205 as treatment for COVID-19

Cytocom receives FDA clearance of IND for Phase 2 clinical trial of CYTO-205 as treatment for COVID-19

FORT COLLINS -- Cytocom, Inc. announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for a Phase 2 clinical trial to evaluate the safety... Read More

Thursday March 18, 2021 0 comments Tags: Fort Collins, Cytocom, CYTO-205, Michael Handley, FDA

Fusion Robotics receives FDA 510(k) clearance for spinal navigation & robotics system

Fusion Robotics receives FDA 510(k) clearance for spinal navigation & robotics system

BOULDER -- Fusion Robotics LLC, a spinal robotics and navigation company, announced receiving 510(k) clearance to market the company’s 3D imaging compatible navigation and robotic targeting... Read More

Friday February 26, 2021 0 comments Tags: Boulder, Fusion Robotics, Brad Clayton, Kevin Foley, FDA

New COVID-19 antibody test receives emergency use authorization by FDA

New COVID-19 antibody test receives emergency use authorization by FDA

DENVER --Scientists at the University of Denver have tested a new antibody test for COVID-19 that can predict if a patient will experience mild versus more severe symptoms of the virus. The... Read More

Thursday February 4, 2021 0 comments Tags: Denver, University of Denver, COVID-19, FDA, Jeremy Haefner

Ampio gets FDA feedback on proposed modifications to special protocol assessment for Ampion

Ampio gets FDA feedback on proposed modifications to special protocol assessment for Ampion

ENGLEWOOD -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) today announced it received guidance from the U.S Food Drug Administration regarding the impact of COVID-19 on its Phase III clinical... Read More

Wednesday December 30, 2020 0 comments Tags: Englewood, Ampio Pharmaceuticals, Ampion, COVID-19, FDA

Clovis Oncology submits Investigational New Drug applications to FDA for FAP-2286 for therapeutic and imaging clinical trial

Clovis Oncology submits Investigational New Drug applications to FDA for FAP-2286 for therapeutic and imaging clinical trial

BOULDER -- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced it has completed submission of two Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA) for... Read More

Tuesday December 29, 2020 0 comments Tags: Boulder, Clovis Oncology, Patrick J. Mahaffy, FAP-2286, FDA

Ampio enters into collaborative research agreements to explore additional clinical indications for Ampion

Ampio enters into collaborative research agreements to explore additional clinical indications for Ampion

ENGLEWOOD -- Ampio Pharmaceuticals, Inc . (NYSE American: AMPE) announced it has entered into two collaborative research agreements to explore new clinical indications for its immunomodulatory drug,... Read More

Monday December 14, 2020 0 comments Tags: Englewood, Ampio Pharmaceuticals, Ampion, FDA, COVID-19

SomaLogic announces FDA collaboration to advance biosimilar development

SomaLogic announces FDA collaboration to advance biosimilar development

BOULDER -- SomaLogic, Inc . announced an agreement with the U.S. Food and Drug Administration’s Division of Applied Regulatory Science to evaluate the utility of large-scale analysis of proteins... Read More

Monday November 2, 2020 0 comments Tags: Boulder, SomaLogic, FDA, Stephen Williams, SomaScan Platform

FDA grants IND and approves clinical trial protocol of inhaled Ampion for COVID-19 patients

FDA grants IND and approves clinical trial protocol of inhaled Ampion for COVID-19 patients

ENGLEWOOD-- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) announced it has received an Investigational New Drug designation from the U.S. Food and Drug Administration, allowing the company to... Read More

Monday September 21, 2020 0 comments Tags: Englewood, Ampio Pharmaceuticals, Ampion, COVID-19, FDA