FDA awarded grants to fund clinical trials to advance development of products for treatment of rare diseases
On Oct. 8, 2020, the FDA announced that it had awarded six new clinical trial research grants to…
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Biotechnology | COVID-19 | Diagnostics | FDA
Abbott’s released ID NOW COVID-19 interim clinical study results to provide facts on clinical performance
On Oct. 7, 2020, in a continuing effort to provide the facts about ID NOW to support public…
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FDA amended EUA for Hologicﾒs Aptima SARS-CoV-2 assay to Include COVID-19 testing of asymptomatic individuals
On Oct. 6, 2020, Hologic announced that its Aptimaﾮ SARS-CoV-2 assay, which initially received Emergency Use Authorization (EUA)…
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FDA broadly supported Oragenicsﾒ pre-IND development program for its SARS-CoV-2 vaccine
On Oct. 6, 2020, Oragenics announced receipt of feedback to its Type B Pre-IND Meeting Request from the…
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FDA awarded contract to Stanford University to perform in-depth analysis of tissue samples to learn how SARS-CoV-2 causes COVID-19
On Oct. 5, 2020, the FDA awarded a research contract to the Stanford University School of Medicine to…
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Data from Corvus phase 1 study of CPI-006 continued to support its potential as treatment for COVID-19
On Oct. 5, 2020, Corvus Pharmaceuticals announced that it has initiated a Phase 1 study to investigate a…
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FDA approved drug combination for treating mesothelioma
On Oct. 1, 2020, the FDA approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment…
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LabCorp COVID-19 molecular test innovation received FDA authorization
On Oct. 2, 2020, LabCorp announced that it had received an Emergency Use Authorization (EUA) from the FDA…
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Oxford Immunotec announced FDA clearance of the T-SPOT.TB test for use in pediatrics over the age of two
On Sept. 29, 2020, Oxford Immunotec announced that it had received clearance from the FDA to amend the…
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Windtree announced FDA acceptance of IND application for phase 2 clinical trial studying KL4 Surfactant in acute lung injury in adults with COVID-19
On Sept. 29, 2020, Windtree Therapeutics announced that FDA had accepted its Investigational New Drug application for a…
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Hologic granted FDA Emergency Use Authorization for asymptomatic COVID-19 testing with Panther Fusion SARS-CoV-2 assay
On Sept. 28, 2020, Hologic announced that its Panther Fusionﾮ SARS-CoV-2 assay had received Emergency Use Authorization (EUA)…
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Biotechnology | COVID-19 | FDA | Infectious Disease | NIH | Vaccine
INOVIO reported FDA partial clinical hold for planned phase 2/3 trial of COVID-19 vaccine candidate INO-4800
On Sept. 28, 2020, INOVIO announced the U.S. Food and Drug Administration (FDA) had notified the company that…
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FDA took actions to help lower US prescription drug prices
On Sept. 24, 2020, the U.S. Department of Health and Human Services and the U.S. Food and Drug…
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FDA authorized first point-of-care antibody test for COVID-19
On Sept. 23, 2020, the FDA issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care…
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FDA launched the Digital Health Center of Excellence
On Sept. 22, 2020, the FDA announced it had launched the Digital Health Center of Excellence within the…
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Roche launched new quantitative antibody test to measure SARS-CoV-2 antibodies, to support the evaluation of vaccines
On Sept. 18, 2020, Roche announced the launch of its Elecsys Anti-SARS-CoV-2 S antibody test for markets accepting…
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3CL protease inhibitor NLC-001 added to COVID-19-focused joint venture between Todos Medical and NLC Pharma
On Sept. 17, 2020, Todos Medical announced that NLC Pharma had added the dietary supplement NLC-001 to its…
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AXIM Biotechnologies filed Emergency Use Authorization with COVID-19 rapid diagnostic test for neutralizing antibodies
On Sept. 16, 2020, AXIM Biotechnologies announced that it had filed an Emergency Use Authorization (EUA) application with…
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FDA contracted with global partners to analyze coronavirus samples
On Sept. 15, 2020, the U.S. Food and Drug Administration (FDA) awarded a $5.4 million research contract to…
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Vaxart announced FDA clearance of IND application for oral COVID-19 vaccine
On Sept. 14, 2020, Vaxart announced that the U.S. Food and Drug Administration (FDA) has completed its review…
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Biotechnology | Clinical Research | COVID-19 | FDA | Vaccine
BioNTech and Pfizer proposed expansion of pivotal COVID-19 vaccine trial
On Sept. 12, 2020, Pfizer and BioNTech announced that they had submitted an amended protocol to the FDA…
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Todos Medical announced commercial launch of COVID-19 qPCR test kits in the U.S.
On Sept. 11, 2020, Todos Medical announced that the U.S. Food and Drug Administration (FDA) has added the…
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COVID-19 | FDA | HIV | Infectious Disease | Vaccine
Pfizer and BioNTech to potentially supply EU with 200 million doses of mRNA-based vaccine candidate against SARS-CoV-2
On Sept. 9, 2020, Pfizer and BioNTech announced that they had concluded exploratory talks with the European Commission…
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FDA approved Trelegy Ellipta as first once-daily single inhaler triple therapy for treatment of both asthma and COPD in the U.S.
On Sept. 9, 2020, GlaxoSmithKline and Innoviva announced the U.S. Food and Drug Administration (FDA) had approved a…
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INOVIO added Thermo Fisher Scientific to global manufacturing consortium
On Sept. 8, 2020, INOVIO announced that Thermo Fisher Scientific, the world leader in serving science, had signed…
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OraSure’s ORAcollect-RNA device Included in EUA granted to MiraDx for SARS-CoV-2 test
On Sept. 3, 2020, OraSure Technologies announced that its ORAcollect-ﾷRNA (OR-100) collection device was included along with other…
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Roche received FDA Emergency Use Authorization for the cobas SARS-CoV-2 & influenza A/B test for use on cobas 6800/8800 systems
On Sept. 3, 2020, Roche announced that the cobas SARS-CoV-2 & Influenza A/B Test for use on the…
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Roche received FDA approval for first HIV-1/HIV-2 Qualitative test on the cobas 6800/8800 Systems in the fight against HIV/AIDS
On Sept. 1, 2020, Roche announced FDA approval for the cobas HIV-1/HIV-2 Qualitative Test for use on the…
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T2 Biosystems received FDA Emergency Use Authorization for COVID-19 molecular diagnostic test
On Aug. 31, 2020, T2 Biosystems announced that it received FDA emergency use authorization (EUA) for its COVID-19…
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Gilead’s Investigational Antiviral Veklury® (Remdesivir) Receives U.S. Food and Drug Administration EUA for Treatment of Patients With Moderate COVID-1
On Aug. 28, 2020, Gilead Sciences announced the U.S. Food and Drug Administration (FDA) expanded the Emergency Use…
