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…
Humanigen announced peer-reviewed publication demonstrating clinical and economic benefits of lenzilumab
On Jan. 18, 2021, Humanigen announced a peer-reviewed publication in the Journal of Medical Economics citing the clinical…
UK announced largest ever health research programme to transform the prevention, detection and treatment of diseases
On Jan. 17, 2022, Our Future Health announced the launch of UKﾒs largest ever health research programme to…
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…
USDA confirmed highly pathogenic avian influenza in a wild bird in South Carolina
On Jan. 14, 2022, the U.S. Department of Agriculture’s (USDA) National Veterinary Services Laboratories confirmed a highly pathogenic…
CDC study showed flu vaccination prevented severe flu Illness in U.S. children
On Jan. 13, 2022, the Centers for Disease Control and Prevention announced a study published in the journal…
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…
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…
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…
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…
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…
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…
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…
First successful transplant of porcine heart into adult human with end-stage heart disease
On Jan. 10, 2022, in a first-of-its-kind surgery, a 57-year-old patient with terminal heart disease received a successful…
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…
DNA from air could revolutionize the way we measure animal biodiversity
On Jan. 6, 2022, two new studies published in the journal Current Biology showed that environmental DNA (eDNA)…
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 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…
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….
Hologic added Aptima SARS-CoV-2 assay to its Global Access Initiative in resource-limited countries
On Jan 5, 2022, Hologic the addition of the Aptimaﾮ SARS-CoV-2 assay to its Global Access Initiative, a…
Revelar Biotherapeutics and Twist Bioscience announced RBT-0813 neutralized SARS-CoV-2 Omicron and Delta variants
On Jan 5, 2022, Revelar Biotherapeutics and Twist Bioscience announced that RBT-0813 binded to and neutralized the Omicron…
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…
Amyris and Immunitybio completed joint venture for next generation Covid-19 RNA vaccine
On Jan. 3, 2022, Amyris and ImmunityBio announced the completion of a previously announced joint venture agreement to…