Moderna announced first participant dosed in phase 2 study of Omicron-specific booster candidate and publication of data
On Jan. 26, 2022, Moderna announced that the first participant had been dosed in the Phase 2 study…
COVID-19 | FDA | Life Science History | NIH
Mix-and-match trial found additional dose of COVID-19 vaccine safe, immunogenic
On Jan. 26, 2022, the NIH announced that adults who had previously received a full regimen of any…
Pfizer and BioNTech initiated study to evaluate Omicron-based COVID-19 vaccine in adults 18 to 55 years of age
On Jan. 25, 2022, Pfizer and BioNTech announced the initiation of a clinical study to evaluate the safety,…
University of Missouri researchers identified mutations of Delta, Delta Plus variants
On Jan. 25, 2022, researchers at the University of Missouri announced they had identified the highly prevalent, specific…
Cepheid received Health Canada license for Xpert Xpress CoV-2/Flu/RSV plus
On Jan. 25, 2022, Cepheid announced that Health Canada had issued Cepheid a medical device license for Xpert…
Pfizer and BioNTech published data from two studies on COVID-19 vaccine-induced antibodies ability to neutralize SARS-CoV-2 Omicron variant
On Jan. 24, 2022, Pfizer and BioNTech announced the publication of new results from two laboratory studies demonstrating…
Anixa Biosciences and MolGenie announced early potency analysis of SARS-CoV-2 protease inhibitor
On Jan. 24, 2022, Anixa Biosciences announced that the company and its partner, MolGenie, had synthesized a compound…
‘Ultrapotent’ antibodies neutralized SARS-CoV-2 variants in NIAID study
On Jan. 20, 2022, scientists from the National Institute of Allergy and Infectious Diseases (NIAID) announced that they…
FDA approved Veklury (Remdesivir) for treatment of non-hospitalized patients at high risk for COVID-19 disease progression
On Jan. 20, 2022, Gilead Sciences announced that the U.S. Food and Drug Administration had granted expedited approval…
Australia Therapeutic Goods Administration granted provisional registration for Novavax COVID-19 vaccine
On Jan. 19, 2022, Novavaxa announced that Australia’s Therapeutic Goods Administration had granted approval for provisional registration of…
Brazilian Health Regulatory Agency authorized Sorrento phase 2 clinical trial of COVI-MSC in COVID-19l long-hauler patients
On Jan. 18, 2022, Sorrento Therapeutics announced receipt of clearance from the Brazilian regulatory agency (ANVISA) to proceed…
Merck and Ridgeback announced supply agreement with UNICEF for molnupiravir, investigational oral antiviral COVID-19 medicine
On Jan. 18, 2022, Merck and Ridgeback Biotherapeutics announced the signing of a long-term supply agreement with the…
COVAX delivered its 1 billionth COVID-19 vaccine dose
On Jan. 16, 2022, the WHO announced that it had shipped 1.1 million COVID-19 vaccines to Rwanda on…
WHO recommended two new drugs to treat patients with COVID-19
On Jan. 14, 2022, the WHO announced that it had recommended two new drugs for COVID-19, providing yet…
U.S. FDA authorizd InteliSwabﾙ COVID-19 rapid tests for at-home testing for delta variant detection
On Jan. 13, 2022, OraSure Technologies that its InteliSwabﾮ COVID-19 rapid tests detected the Omicron variant as effectively…
DoD awarded contracts to purchase COVID-19 antigen OTC test kits in support of POTUS’ 500 million free at-home COVID-19 Tests
On Jan. 14, 2022, the U.S. Department of Defense, in coordination with the U.S. Department of Health and…
South Korea Ministry of Food and Drug Safety approved Novavax COVID-19 vaccine
On Jan. 12, 2022, Novavax and SK bioscience, a vaccine business subsidiary of Korea-based SK Group, announced that…
Positive results of Pfizer’s phase 3 study exploring co-administration of PREVNAR 20 with Pfizer-BioNTech COVID-19 vaccine released
On Jan. 12, 2022, Pfizer announced positive top-line results from a Phase 3 study describing the safety and…
BioNTech and InstaDeep developed and successfully tested early warning system to detect high-risk SARS-CoV-2 variants
On Jan. 11, 2022, Pfizer and BioNTech announced that the U.S. Food and Drug Administration had expanded the…
GSK and Vir Biotech announced U.S. government purchase of sotrovimab for treatment of COVID-19
On Jan. 11, 2022, GlaxoSmithKline and Vir Biotechnology announced the US Government had purchased an additional 600,000 doses…
Novartis and Molecular Partners reported positive topline data from Phase 2 study for ensovibep antiviral therapeutic for COVID-19
On Jan. 10, 2022, Novartis Molecular Partners announced that Part A of the EMPATHY clinical trial that compared…
Novavax and Serum Institute filed for Emergency Use Authorization of Novavax’ COVID-19 vaccine in South Africa
On Jan. 10, 2022, Novavax and Serum Institute of India announced a regulatory submission to the South African…
Biden-Harris administration required insurance and group health plans to cover cost of at-home COVID-19 tests
On Jan. 10, 2022, the Biden-Harris Administration announced it was requiring insurance companies and group health plans to…
DoD awarded contract to Revival Health to purchase COVID-19 Antigen OTC kits in support of POTUS’ 500 million free at-home COVID-19 rests
On Jan. 7, 2022, the Department of Defense, in coordination with the U.S. Department of Health and Human…
Humanigen announced target enrollment in phase 2/3 ACTIV-5/BET-B trial of Lenzilumab for treatment of COVID-19 was met
On Jan. 5, 2021, Humanigen announced that target enrollment in the Phase 2/3 ACTIV-5/BET-B study had been achieved….
Pfizer and BioNTech signed global collaboration agreement to develop first mRNA-based shingles vaccine
On Jan. 5, 2022, Pfizer and BioNTech announced a new research, development and commercialization collaboration to develop a…
COVID-19 | FDA | Life Science History | NIH
NRx Pharmac submited EUA Application to US FDA for ZYESAMIﾮ (aviptadil) to treat patients at risk of death from COVID-19
On Jan 5, 2022, NRx Pharmaceuticals announced that it had submitted an application for Emergency Use Authorization (EUA)…
Pfizer provided U.S. Government with additional 10 million treatment courses of oral therapy to help combat COVID-19
On Jan. 4, 2022, Pfizer announced that the U.S. government had committed to purchasing an additional 10 million…
Tonix Pharma announced exclusive collaboration with Kansas State University to develop LNP-Free mRNA vaccines
On Jan. 4, 2022, Tonix Pharmaceuticals announced an exclusive option agreement and research collaboration with Kansas State University…
Pfizer and BioNTech received U.S. FDA EUA of COVID-19 vaccine booster for individuals 12 years of age and older
On Jan. 3, 2022, Pfizer and BioNTech announced that the U.S. Food and Drug Administration had expanded the…