Diffusion Pharma announced FDA Accelerated Review of TSC clinical development plan to treat COVID-19 patients with ARDS
On May 5, 2020, Diffusion Pharmaceuticals announced the FDA accelerated its review of the Companyï¾’s clinical development plan…
Biotechnology | COVID-19 | FDA
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…
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 announced the selection of a development candidate for…
Cerus announced FDA approval for INTERCEPT Blood System for plasma with alternate plastic disposable kits
On May 4, 2020, Cerus announced FDA regulatory approval for manufacture of INTERCEPT plasma with a new, alternative…
DNA Genotek’s ORAcollect RNA kit included in EUA granted to Biocerna SARS-CoV-2 test
On May 4, 2020, DNA Genotek, a subsidiary of OraSure Technologies, announced that its ORAcollect RNA kit (OR-100)…
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 FDA has issued an Emergency Use Authorization for its new…
Gilead announced investigational antiviral remdesivir received FDA Emergency Use Authorization for treatment of COVID-19
On May 1, 2020, Gilead announced the FDA granted emergency use authorization (EUA) for the investigational antiviral remdesivir…
FDA issued Emergency Use Authorization for potential COVID-19 treatment
On May 1, 2020, the FDA issued an Emergency Use Authorization (EUA) for the investigational antiviral drug remdesivir…
FDA approved DARZALEX FASPRO, a new subcutaneous formulation of Daratumumab in treatment of patients with Multiple Myeloma
On May 1, 2020, Janssen Pharma, a Johnson & Johnson company, announced the U.S. Food and Drug Administration…
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…
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…
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…
Neurocrine Biosciences announced FDA approval of ONGENTYS as treatment for patients with Parkinson’s Disease
On Apr. 27, 2020, Neurocrine Biosciences announced the FDA approved once-daily oral ONGENTYS (opicapone) 25 mg and 50…
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…
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…
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…
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…
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…
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…
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…
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…
Biotechnology | Disease | FDA | Life Science News | 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),…
Quidel’s Lyra direct SARS-CoV-2 assay submitted for Emergency Use Authorization for molecular detection of COVID-19
On Apr. 22, 2020, Quidel announced it has applied for an Emergency Use Authorization (EUA) for the Lyraï¾®…
FDA granted ALung Emergency Use Authorization to Hemolung Respiratory Assist System for treatment of COVID-19
On Apr. 22, 2020, ALung Technologies announced the U.S. Food and Drug Administration (FDA) granted the Company Emergency…
FDA approved IMBRUVICA (ibrutinib) plus Rituximab for ttreatment of patients with CLL
On Apr. 21, 2020, the Janssen Pharmaceutical Companies of Johnson & Johnson announced U.S. Food and Drug Administration…
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…
ViralClear submited application for Vicromax through FDAs Coronavirus Treatment Acceleration Program for accelerated clinical trials
On Apr. 21, 2020, BioSig Technologies announced that subsidiary ViralClear Pharmaceuticals, had submitted an application for Vicromax(tm) (merimepodib,…
LabCorp COVID-19 at-home test kit received FDA Emergency Use Authorization
On Apr. 21, 2020, LabCorpï¾® announced it has received an Emergency Use Authorization (EUA) from the FDA. The…
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…
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…