FDA granted IND approval for phase 2 clinical trial of Innovation Pharmasﾒ Brilacidin for treating COVID-19
On Dec. 21, 2020, Innovation Pharma announced that the FDA had approved the Companyﾒs Investigational New Drug (IND)…
First patients, including a COVID-19 patient, treated with Abiomed’s ECMO technology
On Dec. 21, 2020, Abiomed announced the first two patients in the world had been treated with the…
FDA granted IND approval for phase 2 clinical trial of Innovation Pharma’s Brilacidin for treating COVID-19
On Dec. 21, 2020, Innovation Pharmaceuticals announced that the FDA had approved the Companyﾒs Investigational New Drug (IND)…
Labcorp made Pixel At-Home COVID-19 Collection Kit available through Walgreens Find Careﾮ
On Dec. 21, 2020, LabCorp and Walgreens announced that the Pixel by Labcorpﾙ At-Home COVID-19 Collection Kit is…
Novan engaged Catalent to develop intranasal formulation of berdazimer sodium for COVID-19 program
On Dec. 21, 2020, Novan announced it had entered into a Master Services Agreement (MSA) with Catalent, which…
Pfizer and BioNTech received CHMP positive opinion for their COVID-19 vaccine
On Dec. 21, 2020, Pfizer and BioNTech announced that the Committee for Medicinal Products for Human Use (CHMP)…
Pfizer and BioNTech received authorization in the European Union for COVID-19 vaccine
On Dec. 21, 2020, Pfizer and BioNTech announced that the European Commission (EC) had granted a conditional marketing…
OraSure updated Its Emergency Use Authorization application for lab-based oral SARS-CoV-2 antibody test
On Dec. 21, 2020, OraSure Technologies disclosed that the FDA had requested additional information as part of its…
CDC’s ACIP announced interim recommendation for use of Moderna COVID-19 Vaccine
On Dec. 19, 2020, after a transparent, evidence-based review of available data, the Advisory Committee on Immunization Practices…
Pfizer and BioNTech to supply the European Union with 100 million additional doses of COMIRNATY
On Dec. 19, 2020, Pfizer and BioNTech announced they supplying an additional 100 million doses of COMIRNATY the…
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,…
Biotechnology | Diagnostics | Disease | FDA | Life Science News | Oncology | Radiology | Therapeutics
FDA approved first adjuvant therapy for most common type of lung cancer
On Dec. 18, 2020, the the U.S. Food and Drug Administration (FDA) approved AstraZeneca’s Tagrisso (osimertinib) as the…
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…
National Research Council of Canada supported development of 4 COVID-19 therapeutic candidates
On Dec. 18, 2020, the National Research Council of Canada (NRC) announced it was providing advisory services and…
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…
FDA issued Emergency Use Authorization for second COVID-19 vaccine
On Dec. 18, 2020, the FDA issued an emergency use authorization (EUA) for the second vaccine for the…
Lilly began pragmatic study of neutralizing antibody bamlanivimab (LY-CoV555) for COVID-19 in New Mexico
On Dec. 18, 2020, Eli Lilly announced plans to begin a new pragmatic study of bamlanivimab (LY-CoV555) in…
EC exercised option for additional 80 million doses of Moderna’s COVID-19 vaccine candidate
On Dec. 18, 2020, Moderna announced that the European Commission (EC) had exercised its option to purchase an…
Moderna announced FDA authorization of Moderna COVID-19 vaccine in U.S.
On Dec. 18, 2020, Moderna announced that the U.S. Food and Drug Administration (FDA) had authorized the emergency…
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…
CDC Advisory Committee on Immunization Practices recommended vaccination with Moderna’s COVID-19 vaccine
On Dec. 18, 2020, Moderna announced that the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on…
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…
Biotechnology | COVID-19 | FDA | Life Science News | Vaccine
Moderna received FDA Advisory Committee vote supporting EUA for vaccine against COVID-19 in the U.S.
On Dec. 17, 2020, Moderna confirmed that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological…
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…