Clovis Oncology submits NDA for rucaparib to treat recurrent ovarian cancer

Clovis Oncology submits NDA for rucaparib to treat recurrent ovarian cancer

BOULDER -- Clovis Oncology (NASDAQ: CLVS) today announced it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for rucaparib as maintenance... Read More

Tuesday October 10, 2017 0 comments Tags: Boulder, Clovis Oncology, Rucaparib, Patrick J. Mahaffey, FDA

InDevR licenses FDA influenza antibodies for VaxArray potency platform

InDevR licenses FDA influenza antibodies for VaxArray potency platform

BOULDER -- InDevR , a Boulder-based progressive analytical technology and life science instrumentation company, today announced it has entered into an agreement to license monoclonal antibodies... Read More

Tuesday January 17, 2017 0 comments Tags: Boulder, InDevR, FDA, VaxArray, Dr.Kathy Rowlen, influenza

Ampio: FDA discussions continue on best path forward for Ampion

Ampio: FDA discussions continue on best path forward for Ampion

ENGLEWOOD -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced it is continuing discussions with the CBER Division of the FDA to determine the best path forward to obtain a Biological... Read More

Thursday November 10, 2016 0 comments Tags: Englewood, Ampio Pharmaceuticals, Ampion, Michael Macaluso, FDA

Taiga Biotechnologies awarded Orphan Drug Designation for experimental stem therapy

Taiga Biotechnologies awarded Orphan Drug Designation for experimental stem therapy

AURORA -- The Food and Drug Administration (FDA) has given Taiga Biotechnologies Inc. Orphan Drug Designation for an experimental product designed to treat children with a rare immune deficiency... Read More

Tuesday June 14, 2016 0 comments Tags: Aurora, Taiga Biotechnologies, Brian Turner, TBX-1400, FDA, Yosef Refaeli

CBSA, Sen. Bennet host FDA commissioner Robert Califf at Life Science Roundtable

CBSA, Sen. Bennet host FDA commissioner Robert Califf at Life Science Roundtable

DENVER -- Colorado BioScience Association (CBSA) and Colorado Senator Michael Bennet hosted close to 50 Colorado life science industry leaders to meet FDA Commissioner Dr. Robert Califf as... Read More

Monday April 4, 2016 0 comments Tags: Denver, CBSA, CBSA Life Sciences Industry Roundtable, Sen. Michael Bennet, April Giles, David Brunel, FDA, Dr. Robert Califf

Cerapedics gets FDA approval for i-FACTOR bone graft to repair cervical disc degeneration

Cerapedics gets FDA approval for i-FACTOR bone graft to repair cervical disc degeneration

WESTMINSTER -- Cerapedics , a privately-held orthobiologics company, announced the FDA has approved the companys Premarket Approval application for i-FACTOR Peptide Enhanced Bone Graft for use in... Read More

Wednesday November 4, 2015 0 comments Tags: Westminster, Cerapedics, i-FACTOR, bone grafts, Jeffrey G. Marx, Glen Kashuba, FDA

PharmaJet removes pain and fear of flu shot needle

PharmaJet removes pain and fear of flu shot needle

Golden company is first to get FDA approval for needle-free injections By Barbara Hall InnovatioNews GOLDEN -- Imagine getting a shot without a sting. Heather... Read More

By: Barbara Hall Wednesday October 1, 2014 0 comments Tags: FDA, Golden, Kathy Callender, PharmaJet

PharmaJet gets first FDA approval to use needle-free injection technology for flu shots

PharmaJet gets first FDA approval to use needle-free injection technology for flu shots

GOLDEN - PharmaJet , developer of a needle-free injection technology for administering medications and vaccines, has received approval from the FDA for its Stratis 0.5mL Needle-Free Jet... Read More

By: InnovatioNews Tuesday August 19, 2014 0 comments Tags: Afluria vaccine, FDA, Golden, influenza, PharmaJet, PharmaJet Stratis, Ron Lowy