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…
NeuroRx and Relief Therapeutics announce enrollment of 150 patients in phase 2b/3 trial of RLF-100â„¢ 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…
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…
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…
COVID-19 | FDA | Life Science History | NIH
Moderna completed case accrual for first planned interim analysis of mRNA vaccine against COVID-19
On Nov. 11, 2020, Moderna announced that it had completed case accrual for the first interim analysis of…
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…
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)…
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…
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 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 authorized phase 1 trial of ImmunityBioï¾’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…
FDA approved first treatment for Ebola virus
On Oct. 14, 2020, the FDA approved Regeneron Pharmaceutical’s Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three…
Vaxart announced positive hamster challenge study data for its oral COVID-19 vaccine
On Oct. 14, 2020, Vaxart announced that the FDA had completed its review of the Companyï¾’s Investigational New…
Tevogen Bio submitted IND for T cell treatment in COVID-19
On Oct. 14, 2020, Tevogen Bio announced that its Investigational New Drug (IND) application to develop a COVID-19…
Regeneron’s antibody cocktail REGN-EB3 (Inmazeb) first FDA-approved treatment for Ebola (Zaire Ebolavirus)
On Oct. 14, 2020, Regeneron announced that the FDA had approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the…
Roche launched laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients
On Oct. 13, 2020, Roche announced that it intended to launch a high-volume SARS-CoV-2 Antigen test as an…
New CAR T-Cell therapy approved and available at Roswell Park for lymphoma patients
On Oct. 13, 2020, Roswell Park Comprehensive Cancer Center announced that it had been approved to administer the…
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…
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…