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 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...
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...
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 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...
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...
Convalescent plasma from patients who have recovered from COVID-19 reduced hospitalizations by nearly 50% for outpatients infected with the virus in a nationwide, multicenter clinical trial.
Johns...
FDA recently granted emergency use authorization for Siemens Healthineers’ CLINITEST Rapid COVID-19 Antigen Self-Test.
The nasal swab test is a point-of-care cassette test that does not require...
FDA recently expanded the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine booster to include individuals 12 years of age and older.
The authorization follows two months after the...
Johnson & Johnson recently announced that its COVID-19 vaccine, Ad26.COV2.S, was 85 percent effective against coronavirus-related hospitalization in a Phase 3b study.
The South African Medical...
FDA recently granted emergency use authorization to Roche’s COVID-19 At-Home Test for children aged 14 years and older and by an adult for children aged two to 13 years.
The COVID-19 At-Home...
FDA recently issued an emergency use authorization for Merck’s COVID-19 treatment, molnupiravir, for adults 18 years of age and older.
The agency authorized the treatment for adults with high...
