FDA approved prosthetic implant for above-the-knee amputations
On Dec. 18, 2020, the FDA approved the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System,…
FDA approved first oral hormone therapy for teating advanced prostate cancer
On Dec. 18, 2020, tthe U.S. Food and Drug Administration approved Orgovyx (relugolix) for the treatment of adult…
COVAX announced additional access promising COVID-19 vaccine candidates with global rollout starting 2021
On Dec. 18, 2020, the World Health Organization (WHO) announced that it had arrangements in place to access…
Johnson & Johnson announced agreement with Gavi to supply COVID-19 vaccine candidate to lower-income countries in 2021
On Dec. 18, 2020, Johnson & Johnson announced that its subsidiary Janssen Pharma, will provide up to 500…
Investigational COVID-19 therapeutics evaluated in large clinical trials
On Dec. 17, 2020, NIAID announced that two randomized, controlled Phase 3 clinical trials had begun evaluating investigational…
NIAID study of Coronavirus infection and multisystem inflammatory syndrome in children began
On Dec. 17, 2020, NIAID announced that an observational study had launched to evaluate the short- and long-term…
XPhyto completed successful SARS-COV-2 RT-PCR diagnostic testk kit validation
On Dec. 17, 2020, XPhyto Therapeutics and 3a-diagnostics announced the successful validation of their point-of-care SARS-CoV-2 (COVID-19) RT-PCR…
COVID-19 the leading cause of death in the United States
On Dec. 17, 2020, JAMA reported that the daily U.S. mortality rate for COVID-19 deaths was equivalent to…
Quest Diagnostics and The Commons Project delivered access to lab data through the CommonHealth App
On Dec. 17, 2020, Quest Diagnostics and The Commons Project, a non-profit public trust dedicated to building and…
PRA Health Sciences collaborated with PWNHealth and Fulgent Genetics provided at-home COVID-19 test
On Dec. 17, 2020, PRA Health Sciences announced the enhancement of its COVID-19 Monitoring Program with the addition…
Johnson & Johnson announced Its first phase 3 COVID-19 vaccine trial ENSEMBLE was fully enrolled
On Dec. 17, 2020, Johnson & Johnson announced that the large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) of…
NEJM published positive initial Regeneron antibody cocktail results in non-hospitalized patients with COVID-19
On Dec. 17, 2020, Regeneron announced that the New England Journal of Medicine (NEJM) had published initial clinical…
ACON Laboratories received Emergency Use Authorization for its SARS-COV-2 IgG/IgM rapid test
On Dec. 17, 2020, ACON Laboratories announced that its SARS-COV-2 IgG/IgM Rapid Test has been authorized for emergency…
Abbott’s BinaxNOW COVID-19 rapid rest received FDA Emergency Use Authorization for at-home rapid test
On Dec. 16, 2020, Abbott announced that the FDA had issued Emergency Use Authorization (EUA) for virtually guided…
NIH observational study of coronavirus infection and multisystem inflammatory syndrome in children began
On Dec. 16, 2020, National Institute of Allergy and Infectious Diseases reported that an observational study had launched…
FDA issued new authorization for the BinaxNOW COVID-19 Ag Card Home Test
On Dec. 16, 2020, the U.S. Food and Drug Administration issued a new emergency use authorization (EUA) for…
Heat Biologics announced completion of ZVX-60 vaccine cell line for COVID-19
On Dec. 16, 2020, Heat Biologics announced it had completed its gp96-based COVID-19 vaccine cell line, which is…
SARS-CoV-2 viral genome sequencing data reported from research using Pacific Biosciences Technology
On Dec. 16, 2020, Pacific Biosciences announced initial findings from the companyﾒs research collaboration with Labcorp that was…
BioNTech and Fosun Pharma to supply China with mRNA-based COVID-19 vaccine
On Dec. 16, 2020, BioNTech and Shanghai Fosun Pharmaceutical announced an agreement to supply Mainland China with an…
Meridian received NIH award for supporting rapid development of Revogeneﾮ molecular test for SARS-CoV-2
On Dec. 16, 2020, Meridian Bioscience announced that it had been awarded funding in the amount of approximately…
Abbott received CE Mark for its COVID-19 IgG quantitative antibody blood test
On Dec. 15, 2020, Abbott announced it received had CE Mark for its new quantitative SARS-CoV-2 IgG (Immunoglobulin…
FDA authorized antigen test as first over-the-counter fully at-home diagnostic test for COVID-19
On Dec. 15, 2020, the FDA granted emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home…
TGen identified gene that could explain disparity in COVID-19 effects
On Dec. 15, 2020, TGen, an affiliate of City of Hope announced that it had identified a specific…
Aurinia and Lonza announced exclusive agreement for dedicated Voclosporin manufacturing capacity
On Dec. 15, 2020, Aurinia Pharmaceuticals announced the funding and initiation of an open-label exploratory trial evaluating the…
FDA approved first-of-its-kind Intentional genomic alteration in Line of domestic pigs for human food, potential therapeutic uses
On Dec. 14, 2020, the U.S. Food and Drug Administration (FDA) approved the a first-of-its-kind intentional genomic alteration…
CureVac commenced global pivotal phase 2b/3 trial for COVID-19 vaccine candidate, CVnCoV
On Dec. 14, 2020, CureVac announced that it had enrolled the first participant in the pivotal Phase 2b/3…
Novartis updated on RUXCOVID study of ruxolitinib for hospitalized patients with COVID-19
On Dec. 14, 2020, Novartis announced that the Phase III RUXCOVID study evaluating ruxolitinib on top of standard…
No association found between COVID-19 and Guillain-Barre syndrome
On Dec.14, 2020, neuroscientists at University College London (UCL) announced they had found no significant association between COVID-19…
U.S. Dept of Veterans Affairs began COVID-19 vaccinations
On Dec. 14, 2020, the U.S. Dept. of Veterans Affairs (VA) announced that the New Orleans and Bedford,…
Codagenix and Serum Institute commenced first-in-human trial of COVI-VAC single dose, intranasal COVID-19 vaccine
On Dec. 14, 2020, Codagenix and the Serum Institute of India announced that a Phase 1 clinical trial…