A recent Nature study found that evaluating the performance of FDA-approved medical artificial intelligence (AI) devices in multiple clinical trial sites is crucial to ensuring that the devices perform...
FDA recently authorized marketing of the GI Genius, a medical device that uses artificial intelligence (AI) to assist clinicians in detecting signs of colon cancer.
GI Genius is based on machine...
Gilead recently announced that FDA approved Trodelvy for adults with unresectable, locally advanced, or metastatic triple-negative breast cancer (TNBC).
FDA based its approval on results from a Phase...
FDA recently announced two revisions regarding the number of doses per vial available for Moderna’s COVID-19 vaccine, mRNA-1273.
The agency’s first revision clarifies the number of doses...
TCR2 Therapeutics recently announced that it has signed a long-term, full-binding lease with Alexandra Real Estate Equities for an existing 85,000 square foot cell therapy manufacturing...
Merck recently announced that FDA issued a Complete Response Letter (CRL) in regards to Merck’s supplemental Biologics License Application (sBLA) seeking approval for its monoclonal antibody,...
A new CDC study used real-world evidence to find that mRNA COVID-19 vaccines are highly effective in preventing SARS-CoV-2 infections among healthcare personnel, first responders, and other essential...
Moderna recently announced that the first participants were dosed in the Phase 2/3 study of its COVID-19 vaccine candidate, mRNA-1273, in children six months to up to 12 years of age.
The study,...
A recent study found that COVID-19 antigen test sensitivity is higher in individuals with signs and symptoms of the coronavirus, rather than in those without symptoms present.
In individuals...
FDA recently granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1) COVID-19 diagnostic test.
BioFire RP2.1 is used for the simultaneous qualitative detection of multiple...
Eli Lilly & Company recently announced new data showing that its combination COVID-19 antibody therapy significantly reduced COVID-19 hospitalizations and deaths in high-risk coronavirus...
A recent Pew Charitable Trusts study found that over half (52 percent) of COVID-19 hospitalizations during the first six months of the pandemic included antibiotic...
The Israel Ministry of Health (MoH), Pfizer, and BioNTech recently shared real-world evidence showing that the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, elicited lower incidence rates of coronavirus...
The Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA) recently reaffirmed the benefits of AstraZeneca’s COVID-19 vaccine.
The agencies stated that...
FDA recently issued an emergency use authorization for a sequencing-based COVID-19 diagnostic test.
The T-Detect COVID Test, developed by Adaptive Biotechnologies, is intended to identify individuals...
Researchers recently developed a promising new blueprint for an RNA-based vaccine for malaria, which contains similar properties as the novel RNA COVID-19 vaccines.
Novartis Pharmaceutical and...
GSK recently announced results from a Phase 2 proof-of-concept trial evaluating its investigational monoclonal antibody treatment, otilimab.
The OSCAR study evaluated the efficacy and safety of...
Pfizer and BioNTech recently announced the submission of new data to FDA demonstrating the stability of their COVID-19 vaccine when stored at higher temperatures.
Specifically, the...
Thermo Fisher Scientific recently launched its Vanquish Online 2D-Liquid Chromatography (LC) system, which offers versatility for multidimensional liquid chromatography.
The system offers a robust...
Eli Lilly and Company recently partnered with local health systems to enhance access to crucial COVID-19 antibody therapies.
The partnership will work to launch dedicated infusion center...
