The approval was based on data from the phase 1 CHRYSALIS trial that evaluated Rybrevant in 81 patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease had progressed on or after platinum-based chemotherapy.
Results of qualitative, semi-quantitative, or quantitative SARS-CoV-2 antibody tests should not be interpreted as an indication of a specific level of immunity or protection from SARS-CoV-2 infection.
At 76 weeks, results showed that off-treatment pain scores remained lower than baseline across all linzagolix treatment arms.
The FDA has authorized undiluted, thawed vials of the Pfizer-BioNTech COVID-19 Vaccine to be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to 1 month.
TN-201 is a potentially curative, one-time, AAV-based gene therapy to address genetic hypertrophic cardiomyopathy caused by MYBPC3 gene mutations.
Positive topline results were announced from two phase 3 studies evaluating V114, an investigational 15-valent pneumococcal conjugate vaccine, in pediatric patients for the prevention of invasive pneumococcal disease.
In both trials, BXCL501 demonstrated statistically significant, rapid and durable improvements vs placebo across multiple agitation scales.
Tiopronin is indicated for the prevention of cystine stone formation in patients with severe homozygous cystinuria who are unresponsive to treatment with high fluid intake, alkali, and diet modification.
Results showed both trials of leronlimab did not meet primary or secondary endpoints.
Results from both studies demonstrated that ruxolitinib met the primary endpoint with a greater proportion of patients achieving F-VASI75 at week 24.
