Neurocrine Biosciences announced FDA approval of ONGENTYS as treatment for patients with Parkinson’s Disease
On Apr. 27, 2020, Neurocrine Biosciences announced the U.S. Food and Drug Administration (FDA) had approved once-daily oral…
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Moderna announced IND Submitted to FDA for phase 2 study of mRNA vaccine (mRNA-1273) against novel Coronavirus
On Apr. 27, 2020, Moderna announced it had submitted an Investigational New Drug application to the U.S. Food…
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Diffusion Pharma announced pre-IND submission to FDA of design for TSC trials to treat Acute Respiratory Distress Syndrome in COVID-19
On Apr. 27, 2020, Diffusion Pharmaceuticals announced the pre-IND submission to the FDA of a planned clinical program…
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FDA warns of ‘Off-Label’ use of antimalarial drugs hydroxychloroquine and chloroquine to treat COVID-19 patients
On Apr. 24, 2020, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication regarding known…
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ViralClear submits investigational New Drug Application to FDA for phase II clinical trials for merimepodib
On Apr. 24, 2020, BioSig Technologies announced that subsidiary ViralClear had submitted an Investigational New Drug (IND) application…
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Baxter obtained FDA Emergency Use Authorization for Oxiris blood purification filter for COVID-19 treatment
On Apr. 23, 2020, Baxter announced it had received emergency use authorization (EUA) from the FDA for the…
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The FDA issued an emergency use authorization (EUA) for the Philips Medizin Systeme Boeblingen
On Apr. 22, 2020, the FDA issued an emergency use authorization (EUA) for the Philips Medizin Systeme Boeblingen…
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Caladrius Biosciences planned to assess CLBS119 cell therapy for repair of COVID-19 induced lung damage
On Apr. 23, 2020, Caladrius Biosciences announced the FDA has authorized its investigational new drug application for the…
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LivaNova permitted to modify cardiopulmonary products’ indications for use to include ECMO therapy to address COVID-19
On Apr. 22, 2020, LivaNova announced that several of its cardiopulmonary products are now permitted to be used…
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Biotechnology | Disease | FDA | Oncology | Therapeutics
The FDA approved new therapy for triple negative breast cancer
On Apr. 22, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy),…
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FDA approved IMBRUVICA (ibrutinib) plus Rituximab for ttreatment of patients with CLL
On Apr. 21, 2020, the Food and Drug Administration (FDA) expanded the indication of ibrutinib (IMBRUVICA, Pharmacyclics LLC) to…
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aTyr Pharma announced phase 2 study of ATYR1923 in COVID-19 patients with severe respiratory complications
On Apr. 21, 2020, aTyr Pharma announced the FDA has accepted its Investigational New Drug application to evaluate…
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LabCorp COVID-19 at-home test kit received FDA Emergency Use Authorization
On Apr. 21, 2020, LabCorpﾮ announced it has received an Emergency Use Authorization (EUA) from the FDA. The…
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Biotechnology | COVID-19 | Diagnostics | FDA | Therapeutics
Todos Medical announced FDA Emergency Use Authorization allowed for Gnomegen COVID-19 PCR test kits
On Apr. 21, 2020, Todos Medical announced that Gnomegen has received Emergency Use Authorization from the FDA for…
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Novartis announced plan to initiate clinical study of Jakavi in severe COVID-19 patients
On Apr. 20, 2020, Novartis announced it had reached an agreement with the U.S. Food and Drug Administration…
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Alexion announced plans to initiate phase 3 study of ULTOMIRISﾮ (ravulizumab-cwvz) in hospitalized patients with severe COVID-19
On Apr. 20, 2020, Alexion announced plans to initiate a global Phase 3 study to investigate ULTOMIRISﾮ (ravulizumab-cwvz)…
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Screening of 11,552 compounds identified Innovation Pharma’s Brilacidin as promising Potential inhibitors of novel Coronavirus COVID-19
On Apr. 20, 2020, Innovation Pharma reported that based on molecular screening of 11,552 compounds comprising already FDA-approved…
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Atossa Therapeutics submitted Clinical Investigation approval to FDA for launch of COVID-19 HOPE study
On Apr. 20, 2020, Atossa Therapeutics announced that it had applied to the FDA for approval to commence…
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Biotechnology | COVID-19 | Diagnostics | FDA
Roche developed new serology test to detect COVID-19 antibodies
On Apr. 17, 2020, Roche announced the development and upcoming launch of its Elecsys Anti-SARS-CoV-2 serology test to…
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Biotechnology | Disease | FDA | Oncology | Therapeutics
FDA approved first new drug under international collaboration for patients with HER2-positive metastatic breast cancer
On Apr. 17, 2020, as part of Project Orbis, the U.S. Food and Drug Administration (FDA) approved Seagen’s…
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COVID-19 | FDA | Infectious Disease | Vaccine
Dynavax and Sinovac announced collaboration to develop a Coronavirus (COVID-19) vaccine
On Apr. 16, 2020, Dynavax and Sinovac Biotech, a leading provider of biopharmaceutical products in China, announced that…
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FDA accepted for Priority Review Biologics License Application for REGN-EB3 to treat Ebola
On Apr. 16, 2020, Regeneron announced the U.S. Food and Drug Administration (FDA) had accepted for Priority Review…
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Atossa Therapeutics launched COVID-19 HOPE drug development program
On Apr. 16, 2020, Atossa Therapeutics announced a new drug development program called COVID-19 HOPE. The program used…
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FDA authorized first-of-its-kind low-cost ventilator developed by University of Minnesota
On Apr. 15, 2020, the U.S. Food and Drug Administration (FDA) authorized the production and use of a…
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Orthoﾒs total antibody test for COVID-19 received Emergency Use Authorization from FDA
On Apr. 15, 2020, the FDA announced it granted Emergency Use Authorization to Ortho Clinical Diagnosticsﾒ total antibody…
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Todos Medical received medical importer status with U.S. FDA
On Apr. 15, 2020, Todos Medical announced the U.S. Food and Drug Administration (FDA) has accepted Todos Medical’s application…
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Chembio Diagnostics received Emergency Use Authorization for DPP COVID-19 s for IgG and IgM antibodies
On Apr. 15, 2020, Chembio Diagnostics announced receipt of FDA Emergency Use Authorization (EUA) for its DPP COVID-19…
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NantKwest and ImmunityBio announced therapeutics and vaccines for combatting COVID-19
On Apr. 14, 2020, NantKwest and ImmunityBio announced discussions with the FDA for vaccines and therapeutics to combat…
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FDA authorized Athersys to initiate pvotal clinical trial evaluating MultiStemﾮ cell therapy in patients with COVID-19 induced ARDS
On Apr. 13, 2020, Athersys announced the FDA has authorized the Company to initiate a Phase 2/3 pivotal…
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Pluristem treated first COVID-19 patient in US under FDA single patient expanded access program
On Apr. 13, 2020, Pluristem Therapeutics announced it has treated its first patient suffering from COVID-19 complications in…
