Moderna received U.S. FDA approval for updated COVID-19 vaccine
On Sept. 11, 2023, Moderna announced the U.S. Food and Drug Administration (FDA) had approved the supplemental Biologics…
Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron XBB.1.5-adapted COVID-19 Vaccine in the European Union
On Aug. 30, 2023, Pfizer and BioNTech announced that the Committee for Medicinal Products for Human Use (CHMP)…
CDC reported risk assessment summary for SARS CoV-2 sublineage BA.2.86
On Aug. 23, 2023, the CDC announced it had detected a new SARS-CoV-2 variant labeled BA.2.86. CDC was…
COVID-19 vaccination and boosting during pregnancy benefits pregnant women and newborns
On Aug. 11, 2023, a study funded by the National Institute of Allergy and Infectious Diseases (NIAID) reported…
BD received 510(k) clearance for COVID-19, influenza A/B, RSV molecular combination test
On Aug. 1, 2023, BD announced that the U.S. Food and Drug Administration (FDA) 510(k) had provided clearance…
Report published in Nature detailed transmission of SARS-CoV-2 in free-ranging white-tailed deer in the U.S.
On Jul. 10, 2023, a report published in the journal Nature detailed frequent spillovers of SARS-CoV-2 from humans…
University of Illinois Urbana-Champaign team developed all-species coronavirus test
On Jul. 6, 2023, University of Illinois Urbana-Champaign researchers reported they can detect exposure to the SARS-CoV-2 virus…
U.S. FDA updated COVID-19 vaccines for use in the U.S. beginning in Fall 2023
On Jun. 16, 2023, the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee…
U.S. FDA permitted marketing of first COVID-19 at-home test using traditional premarket review process
On Jun. 6, 2023, the U.S. FDA granted granted marketing authorization for the Cue COVID-19 Molecular Test. The…
WHO announced simple, easy-to-say labels for SARS-CoV-2 Variants of Interest and Concern
On May 31, 2023, the World Health Organization announced it had assigned simple, easy to say and remember…
NIH study identified features of Long COVID neurological symptoms
On May 5, 2023, the National Institutes of Health reported that a study had identified features of Long…
Study raised concerns SARS-CoV-2 evolution outpaces vaccine-generated antibodies
On Apr. 27, 2023, a NIAID-led Phase 2 trial compared two Pfizer bivalent mRNA COVID-19 boosters found that…
Antibiotics do not cut death risk in hospitalized patients with viral respiratory illnesses
On Mar. 24. 2023, antibiotics do not reduce the risk of dying in adults hospitalized with COVID-19, the…
Biotechnology | COVID-19 | NIH | Pharmaceutical | Vaccine
SARS-CoV-2 infection weakens immune-cell response to vaccination
On Mar. 20, 2023, NIH scientists announced that the magnitude and quality of a key immune cellï¾’s response…
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)…
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….
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…
BD received FDA EUA for COVID-19, influenza A/B, RSV combination test
On Feb. 8, 2023, BD announced that it had received Emergency Use Authorization from the U.S. Food and…
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…
FDA announced Evusheld is not currently authorized for emergency use in the U.S.
On Jan. 26, 2023, the U.S. Food and Drug Administration revised the Emergency Use Authorization for Evusheld (tixagevimab…
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…
Moderna received FDA EUA for Omicron-targeting bivalent COVID-19 booster vaccine in children 6 months through 5 years of age
On Dec. 8, 2022, Moderna announced it had received emergency use authorization from the U.S. Food and Drug…
Biotechnology | COVID-19 | Life Science News | Therapeutics | Vaccine | WHO
Novavax Nuvaxovid COVID-19 vaccine approved in Canada for use as a primary series in adolescents
On Dec. 7, 2022, Novavax announced that Health Canada had approved a supplement to a New Drug Submission…
Novavax updated EUA listing for Novavax Nuvaxovid COVID-19 vaccine as pimary series in adolescents and as booster in adults
On Nov. 29, 2022, Novavax announced that the World Health Organization had issued an updated Emergency Use Listing…
Novavax Nuvaxovid COVID-19 vaccine received expanded authorization in Canada as a booster in adults
On Nov. 18, 2022, Novavax announced that Health Canada had granted expanded authorization for Nuvaxovid (COVID-19 Vaccine (Recombinant…
Pfizer and BioNTech advancd next-generation COVID-19 vaccine
On Nov. 16, 2022, Pfizer and BioNTech announced that the companies had initiated a Phase 1 study to…
Novavax Nuvaxovid COVID-19 Vaccine authorized in the United Kingdom for use as a booster in adults
On Nov. 9, 2022, Novavax announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United…
Novavax phase 3 COVID-19 Omicron trial supported continued and future use of prototype vaccine as a booster
On Nov. 8, 2022, Novavax announced topline results from its Phase 3 Boosting Trial for the SARS-CoV-2 rS…
Moderna received Health Canada authorization for second Omicron-targeting bivalent booster
On Nov. 4, 2022, Moderna announced that Health Canada had authorized the use of its BA.4/BA.5 Omicron-targeting bivalent…
Hologic announced contract with BARDA to support IVD approval of COVID assays
On Nov. 2, 2022, Hologic announced that it had been awarded a $19 million contract from the Biomedical…