Eiger announced FDA approval of Zokinvyﾙ (lonafarnib) treatment for Hutchinson-Gilford Progeria Syndrome
On Nov. 20, 2020, Eiger BioPharmaceuticals announced that the FDA had approved ZokinvyTM (lonafarnib) for the treatment of…
Aptima HIV-1 Quant Dx assay receivds additional FDA approval for use as aAid in diagnosis of HIV infection
On Nov. 30, 2020, Hologic announced that the FDA had approved a diagnostic claim for its HIV-1 (human…
Pfizer and BioNTech to submit Emergency Use Authorization Request to the FDA for COVID-19 vaccine
On Nov. 20, 2020, Pfizer and BioNTech announced they submitted a request to the Food and Drug Administration…
Biotechnology | COVID-19 | FDA | Therapeutics
Baricitinib received Emergency Use Authorization from FDA for treatment of hospitalized patients with COVID-19
On Nov. 19, 2020, Eli Lilly and Incyte announced that the FDA had issued an Emergency Use Authorization…
Todos Medical announced positive initial clinical proof-of-concept data for rapid SARS-CoV-2 3CL protease detection assay
On Nov. 18, 2020, Todos Medical announced positive clinical proof of concept data from its lab-based rapid SARS-CoV-2…
FDA authorized first COVID-19 test for self-testing at home
On Nov. 17, 2020, the FDA issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test…
Biotechnology | COVID-19 | FDA | Therapeutics
RedHill’s second COVID-19 candidate cleared by FDA for phase 2/3 Study in symptomatic COVID-19 disease
On Nov. 17, 2020, RedHill Biopharma announced that the U.S. Food and Drug Administration (FDA) had cleared the…
Innovation Pharma announced overseas regulatory filing submitted for COVID-19 clinical study
On Nov. 16, 2020, Innovation Pharmaceuticals announced that an overseas Clinical Trial Application (CTA) has been submitted to…
INOVIO announced initiation of phase 2/3 clinical trial for COVID-19 DNA vaccine candidate, INO-4800
On Nov. 16, 2020, INOVIO announced that it had received clearance from the the U.S. Food & Drug…
Biotechnology | FDA | Oncology | Therapeutics
Agilent received expanded FDA approval for PD-L1 IHC 22C3 pharmDx in triple-negative breast cancer
On Nov. 13, 2020, Agilent Technologies announced it had received U.S. Food and Drug Administration (FDA) approval for…
FDA approved Merck’s KEYTRUDA (pembrolizumab) in combination with chemo for patients with TNBC
On Nov. 13, 2020, Merck announced that the U.S. Food and Drug Administration (FDA) had approved KEYTRUDA, Merck’s…
Biotechnology | COVID-19 | FDA | Therapeutics
NeuroRx and Relief Therapeutics announce enrollment of 150 patients in phase 2b/3 trial of RLF-100™ for Critical COVID-19 with Respiratory Failure
On Nov. 13, 2020, NeuroRx and Relief Therapeutics announced that to-date, 150 patients (out of a targeted enrollment…
Biotechnology | COVID-19 | Diagnostics | FDA
Wren Laboratories launched saliva-based PCR COVID-19 test
On Nov. 12, 2020, Wren Laboratories announced that it had been granted an emergency use authorization by the…
Lilly’s neutralizing antibody bamlanivimab received FDA emergency use authorization for treatment of recently diagnosed COVID-19
On Nov. 9, 2020, the FDA granted Emergency Use Authorization (EUA) for Eli Lilly’s investigational neutralizing antibody bamlanivimab…
EUROIMMUN launched quantitative ELISA to measure SARS-CoV-2 antibodies against viral S1 protein
On Nov. 9, 2020, PerkinElmer announced that EUROIMMUN, a PerkinElmer company, had launched the Anti-SARS-CoV-2 QuantiVacTM ELISA (IgG)…
FDA authorized first test that detected neutralizing antibodies from recent or prior SARS-CoV-2 infection
On Nov. 6, 2020, the FDA authorized the first serology test that detected neutralizing antibodies from recent or…
Biotechnology | COVID-19 | FDA
OraSure’s DNA Genotek subsidiary received FDA EUA for its ORAcollect-RNA saliva collectiondevice for SARS CoV-2
On Nov. 3, 2020, OraSure Technologies announced its DNA Genotek subsidiary has received Emergency Use Authorization from the…
Innovation Pharmaceuticals received pre-IND response from FDA on COVID-19 trial
On Nov. 2, 2020, Innovation Pharma announced receipt of written feedback from the FDA that is in general…
OncoSec announced FDA clearance of IND application for phase 1 clinical trial of CORVax12 vaccine candidate for COVID-19
On Oct. 29, 2020, OncoSec Medical announced that the FDA had approved the Investigational New Drug (IND) application…
AquaBounty announced Mayfield, Kentucky as location for planned 10,000 metric ton salmon farm
On Oct. 29, 2020, AquaBounty Technologies announced that it had identified Mayfield, Kentucky as the potential location for…
PerkinElmer COVID-19 test kit receives FDA Emergency Use Authorization for sample pooling
On Oct. 29, 2020, PerkinElmer announced that the FDA had issued Emergency Use Authorization (EUA) to allow sample…
Emulate collaborated with FDA to apply lung-chip to evaluate safety of COVID-19 vaccines
On Oct. 29, 2020, Emulate announced that it had entered into a Cooperative Research and Development Agreement (CRADA)…
Biotechnology | COVID-19 | FDA | Therapeutics
Lilly announced agreement with US government to supply 300,000 vials of investigational neutralizing antibody bamlanivimab to fight COVID-19
On Oct. 28, 2020, Eli Lilly announced an initial agreement with the U.S. government to supply 300,000 vials…
Nektar Therapeutics announced phase 1b clinical study to evaluate empegaldesleukin for treatment of patients with COVID-19
On Oct. 27, 2020, Nektar Therapeutics announced that it has received FDA clearance for an Investigational New Drug…
ContraFect initiated expanded access to Exebacase for treatment of MRSA bloodstream infections in COVID-19 patients
On Oct. 26, 2020, ContraFect announced that it had initiated an expanded access program to provide exebacase for…
Global clinical trials of COVID-19 vaccine resumed
On Oct. 23, 2020, the U.S. FDA authorised a restart of clinical trials of the ChAdOx1 nCov-2019 Oxford…
Biotechnology | COVID-19 | FDA | Therapeutics
FDA approved Gilead’s antiviral Veklury (remdesivir) for treatment of COVID-19
On Oct. 22, 2020, Gilead Sciences announced that the FDA had approved the antiviral drug Veklury (remdesivir) for…
FDA approved first treatment for COVID-19
On Oct. 22, 2020, the FDA approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric…
Moderna completed enrollment of phase 3 COVE study of mRNA vaccine against COVID-19
On Oct. 22, 2020, Moderna announced that it had completed enrollment of 30,000 participants for the Phase 3…
FDA authorized phase 1 trial of ImmunityBioﾒs novel COVID-19 vaccine candidate hAd5 to drive T cell and antibody immunity
On Oct. 15, 2020, ImmunityBio announced it had received authorization from the FDA to begin a Phase I…