Pfizer recently initiated a Phase 2/3 clinical trial to evaluate the safety, pharmacokinetics, and efficacy of its COVID-19 treatment, Paxlovid, in non-hospitalized, symptomatic pediatric...
Moderna recently announced its global public health strategy through four initiatives to advance mRNA vaccines for infectious diseases.
In the first strategy, Moderna will expand its global public...
The CDC Advisory Committee on Immunization Practices (ACIP) recently recommended Pfizer’s tick-borne encephalitis (TBE) vaccine, TicoVac, to prevent TBE in individuals one year and older.
ACIP...
Moderna and Thermo Fisher Scientific recently announced a 15-year collaboration agreement for dedicated large-scale manufacturing of Moderna’s COVID-19 vaccine and other mRNA vaccines in the...
Moderna recently expanded its mRNA pipeline with three new development programs, including an HSV mRNA vaccine, a varicella-zoster virus (VZV) vaccine, and a checkpoint cancer vaccine.
First, Moderna...
GSK and Sanofi recently announced that they will submit data from their Phase 3 efficacy and booster trials for regulatory approval of their COVID-19 vaccine.
The Phase 3 VAT08 efficacy study...
Moderna and ROVI recently entered into a long-term collaboration to increase capacities for the compounding, aseptic filling, inspection, and manufacturing of mRNA vaccines and medicines over the next...
FDA recently issued emergency use authorization for Eli Lilly and Company’s monoclonal antibody, bebtelovimab, which retains activity against the omicron variant.
The agency authorized the...
Gilead recently announced that its COVID-19 treatment, remdesivir, retained antiviral in vitro activity against variants of concern, including Alpha, Beta, Gamma, Delta, and Omicron.
Researchers...
The Senate recently confirmed Robert Califf as FDA Commissioner after the Biden administration nominated him in early November, according to multiple outlets.
The final vote was 50 to 46, with six GOP...
Pfizer and Valneva recently announced further positive results from the Phase 2 clinical trial evaluating their Lyme disease vaccine candidate, VLA15.
The trial, VLA15-221, enrolled 294 healthy adult...
Pfizer and BioNTech recently initiated a rolling submission seeking to amend FDA’s emergency use authorization of their COVID-19 vaccine to include children six months to four years of age.
The...
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently issued a positive opinion of Pfizer’s COVID-19 treatment, Paxlovid.
The CHMP recommended...
FDA fully approves Moderna’s mRNA COVID-19 vaccine, Spikevax, for individuals 18 years of age and older.
"The full licensure of Spikevax in the US now joins that in Canada, Japan, the European...
Modern and IAVI recently dosed the first two patients in a clinical trial of experimental HIV vaccine antigens at the George Washington University (GWU) School of Medicine and Health Sciences.
The...
FDA recently expedited approval of Gilead’s new drug application for its COVID-19 treatment, Veklury (remdesivir).
The agency expanded the drug to non-hospitalized adults and adolescent patients...
Pfizer recently announced that its COVID-19 treatment, Paxlovid, maintained plasma concentrations many-fold times higher than the amount required to prevent the Omicron variant from replicating in...
Pfizer recently announced positive top-line results from a Phase 3 trial studying its COVID-19 vaccine combined with its pneumococcal 20-valent conjugate vaccine, Prevnar 20.
The study, B74710126,...
Pfizer and Acuitas Therapeutics recently entered into a development and option agreement under which Pfizer will license Acuitas’ lipid nanoparticle (LNP) technology for up to 10 mRNA vaccine or...
Real-world evidence recently confirmed that Johnson & Johnson’sJohnson’s COVID-19 vaccine provides long-lasting protection against breakthrough infections, hospitalizations, and ICU...
