FDA Advisory Committee voted in support of favorable benefit-risk profile for Pfizer’s PAXLOVID
On Mar. 16, 2023, Pfizer announced that the U.S. Food and Drug Administration’s Antimicrobial Drugs Advisory Committee (AMDAC)…
FDA authorized bivalent Pfizer-BioNTech COVID-19 vaccine as booster dose for certain children 6 months through 4 years of age
On Mar. 14, 2023, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) of the…
‘Deaths of Despair’ contributed to 17% rise in Minnesota’s death rate during COVID-19 pandemic
On Mar. 13, 2023, Mayo Clinic published a study that showed the COVID-19 pandemic was linked to a…
QuidelOrtho received de novo FDA authorization for Sofia 2 SARS Antigen+ FIA
On Mar. 8, 2023, QuidelOrtho announced that it had been granted a De Novo request from the U.S….
In a first for imaging, new microscope captured details, 3D motion of molecules in liquid
On Mar. 7, 2023, researchers at Washington University School of Medicine in St. Louis and the Veterans Affairs…
Pfizer and BioNTech submitted for U.S. EUA of Omicron BA.4/BA.5-adapted bivalent COVID-19 booster in children under 5 years
On Mar. 1, 2023, BioNTech and Pfizer announced that they had submitted an application to the U.S. Food…
FDA authorized first OTC at-home test to detect both influenza and COVID-19 viruses
On Feb. 24, 2023, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the…
Moderna to make milestone payments to NIH for COVID vaccine
On Feb. 24, 2023, Moderna announced will make certain contingent development, commercial and regulatory milestone payments to the…
Vekluryï¾® (Remdesivir) reduced risk of mortality in hospitalized COVID-19 patients across all variants in real world study
On Feb. 21, 2023, Gilead Sciences announced positive data from three retrospective real-world studies which demonstrated that initiation…
Higher-Dose and longer duration of Ivermectin not effective with COVID-19
On Feb. 20, 2023, results from a randomized clinical trial of Ivermectin in a higher-hose and longer duration…
Health Canada authorized Moderna’s Omicron-targeting bivalent COVID-19 vaccine in children & cdolescents
On Feb. 17, 2023, Moderna announced that Health Canada had authorized the use of its Omicron-targeting bivalent COVID-19…
Moderna to provide free COVID-19 vaccines after U.S. public health emergency ends
On Feb. 15, 2023, Moderna announced it will continue to offer its COVID-19 vaccines for free, even after…
U.S. Government and Novavax extend partnership for 1.5 million additional doses of Novavax’ COVID-19 vaccine
On Feb. 13, 2023, Novavax announced a modification to its existing agreement with the U.S. Department of Health…
Bivalent boosters provided better protection against severe COVID-19
On Feb. 7, 2023, an NIH funded study by University of North Carolina reported that Bivalent booster vaccines…
U.S. household spread of flu more than doubled during the 2021-2022 season compared to pre-COVID-19 pandemic levels
On Jan. 26, 2023, Centers for Disease Control and Prevention (CDC) reported that U.S. household spread of flu…
Roche launched COVID-19 PCR test to detect the fast spreading XBB.1.5 Omicron sub-variant
On Jan. 25, 2023, Roche and its subsidiary TIB Molbiol announced they had developed a COVID-19 PCR test…
OHSU researchers found immune response to COVID-19 strengthens over time
On Jan. 25, 2023, researchers at Oregon Health & Science University (OHSU) reported that Immunity from COVID-19 appears…
Novavax Nuvaxovid COVID-19 vaccine approved in South Korea as an adult booster
On Jan. 18, 2023, Novavax announced that partner SK bioscience had received expanded manufacturing and marketing approval from…
Single booster dose with updated bivalent COVID-19 vaccine provides broad protection against COVID-19 including Omicron variant
On Jan. 11, 2023, the U.S. Food and Drug Administration reported that a single booster dose with an…
Paxlovid reduced serious risks from Omicron variants
On Jan. 10, 2023, the U.S. National Institutes of Health (NIH) reported that antiviral treatments can help reduce…
NIH launched Home Test to Treat, a pilot COVID-19 telehealth program
On Jan. 5, 2023, the National Institutes of Health, in collaboration with the Administration for Strategic Preparedness and…
Spanish, Italian and French Health Authorities expanded recommendations for use of Novavax COVID-19 vaccine
On Jan. 5, 2023, Novavax announced that Spain’s Public Health Commission, Italy’s Ministry of Health, and France’s Haute…
BioNTech and Fosun Pharma announced regulatory approval of mono- and bivalent COVID-19 vaccine COMIRNATYï¾® in individuals 12 years and older in Hong Kong
On Dec. 23, 2022, BioNTech and Fosun Pharmaceutical announced that they had received the certificates of registration as…
U.S. Department of Health and Human Services increased access to Tamiflu through the Strategic National Stockpile
On Dec. 21, 2022, the U.S. Department of Health and Human Services (HHS), through the Administration for Strategic…
FDA approved Roche’s Actemra for treatment of COVID-19 in hospitalised adults
On Dec. 21, 2022, Roche announced that the U.S. Food and Drug Administration (FDA) had approved Actemraï¾® (tocilizumab)…
Study revealed that duration of exposure to COVID-19 plays major role in risk of catching the virus
On Dec. 20, 2022, the University of Oxford announced study results using data from 7 million people notified…
German Health Authority expanded recommendation for use of Novavax COVID-19 vaccine as a booster
On Dec. 16, 2022, Novavax announced that the Standing Committee on Vaccination (STIKO) in Germany had expanded its…
EMA Committee for Medicinal Products for Human Use rcommended use of Moderna’s BA.1 bivalent COVID-19 booster in children in the EU
On Dec. 16, 2022, Moderna announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use…
Swiss and French health authorities expanded recommendations for use of Nuvaxovid COVID-19 vaccine as booster
On Dec. 11, 2022, Novavax announced that the Switzerland’s Federal Office of Public Health and Francees Haute Autorite…
Biotechnology | COVID-19 | FDA | Influenza | Life Science News | Vaccine
Pfizer and BioNTech received U.S. FDA Fast Track Designation for single-dose mRNA-based vaccine candidate against COVID-19 and influenza
On Dec. 9, 2022, Pfizer and BioNTech announced the companies had received Fast Track Designation from the U.S….