Novavax initiated COVID-19 vaccine clinical trial crossover
On Apr. 5, 2021, Novavax announced the initiation of crossover arms in two ongoing clinical trials of NVX-CoV2373,…
Emergent announced support of manufacturing capacity expansion for Johnson & Johnson’s COVID-19 vaccine
On Apr. 4, 2021, Emergent BioSolutions announced it had received a contract modification to increase the original task…
Emergent announced topline data from NIAID phase 3 ITAC Trial evaluating immunoglobulins as treatment for patients with COVID-19
On Apr. 2, 2021, Emergent BioSolutions announced that topline data from the ITAC trial had demonstrated that the…
Risk of severe Covid-19 from asthma and other respiratory diseases modestly increased
On Apr. 1, 2021, Oxford University scientists announced they had published in The Lancet Respiratory Medicine, a study…
FDA revised Moderna COVID-19 vaccine EUA to increase the number of vaccine doses available
On Apr. 1, 2021, the U.S. Food and Drug Administration (FDA) announced two revisions regarding the number of…
Moderna provided storage update and FDA authorization for 15-doses per vial of COVID-19 vaccine
On Apr. 1, 2021, Moderna announced that based on submitted stability data, the U.S. Food and Drug Administration…
BD received EUA for asymptomatic screening for SARS-CoV-2 through Serial Rapid Antigen Testing
On Apr. 1, 2021, BD (Becton, Dickinson) announced the U.S. Food and Drug Administration (FDA) had granted Emergency…
Pfizer and BioNTech confirmed high efficacy and no serious safety concerns in updated COVID-19 vaccine study
On Apr. 1, 2021, Pfizer and BioNTech announced updated topline results from analysis of 927 confirmed symptomatic cases…
Arbutus Biopharma, X-Chem and Proteros biostructures entered into pan-coronavirus discovery research and license agreement
On Apr. 1, 2021, Arbutus Biopharma, X-Chem and Proteros Biostructures announced hat they had entered into a discovery…
COVID-19 variant vaccine trial began at KPWHRI
On Apr. 1, 2021, Kaiser Permanente Washington Health Research Institute (KPWHRI) announced that an investigational vaccine designed to…
NIH clinical trial evaluating Moderna COVID-19 variant vaccine began
On Mar. 31, 2021, the National Institutes of Health (NIH) announced that an investigational vaccine designed to protect…
Biotechnology | COVID-19 | FDA
Quidel’s QuickVue At-Home OTC COVID-19 Test received EUA for screening use with serial testing
On Mar. 31, 2021, Quidel announced that it had received an Emergency Use Authorization (EUA) from the FDA,…
Pfizer-BioNTech announced positive topline results of pivotal COVID-19 vaccine study in adolescents
On Mar. 31, 2021, Pfizer and BioNTech announced that, in a Phase 3 trial in adolescents 12 to…
T cells recognize recent SARS-CoV-2 variants
On Mar. 30, 2021, the National Institute of Allergy and Infectious Diseases (NIAID) announced that researchers had analyzed…
Celonic and CureVac announced agreement to manufacture over 100 million doses of CureVacﾒs COVID-19 vaccine CVnCoV
On Mar. 30, 2021, CureVac and Celonic Group announced their partnership for the production of CureVacﾒs mRNA-based COVID-19…
Measles vaccine used as base for experimental COVID vaccine
On Apr. 1, 2021, Kaiser Permanente Washington Health Research Institute (KPWHRI) announced that an investigational vaccine designed to…
WHO called for further studies, data on origin of SARS-CoV-2 virus
On Mar. 30, 2021, the report of the WHO international team on their Wuhan field visit, from 14…
BD announced FDA Emergency Use Authorization for combination COVID-19, flu rapid antigen test
On Mar. 30, 2021, BD (Becton, Dickinson) announced the U.S. Food and Drug Administration (FDA) granted emergency use…
OraSure Technologies submitted COVID-19 rapid antigen prescription home self-test to FDA for EUA
On Mar. 30, 2021, OraSure Technologies announced that it had submitted an application to the U.S. Food and…
Qx Therapeutics received FDA authorization with IND for QXT-101 in phase 2 trial for patients with COVID-19 infection.
On Mar. 30, 2021, Qx Therapeutics announced that the FDA had cleared the companyﾒs Investigational New Drug application…
CytoDyn’s leronlimab decreased mortality at 14 days by 82% amongst critically Ill COVID-19 patients
On Mar. 30, 2021, CytoDyn announced further results from its CD12 trial of severe-to-critically ill patients with COVID-19….
Oxford University researchers released cheap, quick COVID-19 antibody test
On Mar. 29, 2021, an international research team led by Oxford University scientists announced they had developed a…
Humanigen reported positive phase 3 results demonstrating Lenzilumabﾙ improved survival without mechanical ventilation with COVID-19
On Mar. 29, 2021, Humanigen announced positive topline results from its Phase 3 clinical trial evaluating the efficacy…
Moderna announced shipment of 100 millionth dose of its COVID-19 vaccine to the U.S. Government
On Mar. 29, 2021, Moderna announced that the Company has shipped the 100-millionth dose of its COVID-19 vaccine…
GSK to manufacture Novavax’ COVID-19 vaccine
On Mar. 29, 2021, Novavax, GSK and the UK Government Vaccines Taskforce announced an agreement in principle to…
Johnson & Johnson announced agreement with African Vaccine Acquisition Trust for COVID-19 vaccine candidate
On Mar. 29, 2021, Janssen Pharmaceutica announced that it had entered into an agreement with the African Vaccine…
Philippines FDA approved the use of leronlimab to treat a COVID-19 patient
On Mar. 29, 2021, CytoDyn announced that the Republic of the Philippines, Department of Health, Food and Drug…
FDA approved first cell-based gene therapy for adult patients with multiple myeloma
On Mar. 27, 2021, the FDA approved Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients…
FDA approved first in the world device to treat patients with congenital heart disease
On Mar. 26, 2021, the U.S. Food and Drug Administration (FDA) approved the first in the world non-surgical…
EMA approved new storage option for Pfizer-BioNTech vaccine, easing distribution and storage of doses
On Mar. 26, 2021, Pfizer and BioNTech announced that the European Medicines Agency (EMA) approved storage of COMIRNATYﾮ…