BIOFIRE respiratory panel 21 (RP21) with SARS-CoV-2 obtained FDA Emergency Use Authorization
On May 4, 2020, bioMerieux announced that BioFire Diagnostics, its subsidiary specialized in syndromic infectious disease testing, has…
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Vir and Alnylam identified RNAi therapeutic development candidate, VIR-2703 (ALN-COV), targeting SARS-CoV-2 for treatment of COVID-19
On May 4, 2020, Vir Biotech and Alnylam Pharma announced the selection of a development candidate for VIR-2703,…
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Roche’s COVID-19 antibody test received FDA Emergency Use Authorization and is available in markets accepting the CE mark
On May 2, 2020, Roche announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency…
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Gilead announced investigational antiviral remdesivir received FDA Emergency Use Authorization for treatment of COVID-19
On May 1, 2020, Gilead announced that the U.S. Food and Drug Administration (FDA) has granted emergency use…
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FDA issued Emergency Use Authorization for potential COVID-19 treatment
On May 1, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for…
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FDA approved DARZALEX FASPRO, a new subcutaneous formulation of Daratumumab in treatment of patients with Multiple Myeloma
On May 1, 2020, the Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (DARZALEX FASPRO, Janssen Biotech.)…
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FDA included ventilator developed by NASA in ventilator Emergency Use Authorization
On Apr. 30, 2020, the FDA included, under the ventilator emergency use authorization (EUA), a ventilator developed by…
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Chimerix received FDA clearance for rolling submission of New Drug Application for brincidofovir as medical countermeasure for smallpox
On Apr. 28, 2020, Chimerix announced it had received clearance from the FDA for a rolling submission of…
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Agriculture | Biotechnology | CRISPR | EPA | FDA | Genomics | USDA
Yield10 Bioscience obtains positive response from USDA-APHIS on regulatory status of CRISPR genome-edited C3007 trait in camelina
On Apr. 27, 2020, Yield10 Bioscience announced that it has obtained a positive response from USDA-APHIS’s Biotechnology Regulatory Services…
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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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Biotechnology | COVID-19 | FDA | Therapeutics
Mateon announced filing of IND with FDA to evaluate antisense drug candidate OT-101 in COVID-19 patients
On Apr. 27, 2020, Mateon Therapeutics announced announced it has submitted an Investigational New Drug application to the…
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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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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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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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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 | 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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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…
