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Eli Lilly, Boehringer’s Jardiance gets FDA nod for type 2 diabetes in children
The approval was based on the findings from the DINAMO Phase 3 trial of patients aged 10-17 years with type 2 diabetes in which Jardiance showed a statistically significant reduction in the primary endpoint
US CDC committee recommends Pfizer, GSK’s RSV vaccines in older patients
In two different votes, the advisory committee agreed that individuals of 60 years and more can get the RSV shots after discussing with their healthcare providers
FDA approves Pfizer’s Talzenna and Xtandi combo for prostate cancer
The approval was backed by the statistically significant and clinically meaningful radiographic progression-free survival (rPFS) data from the Phase 3 TALAPRO-2 trial
US FDA approves argenx’s VYVGART Hytrulo injection for gMG
The FDA approval was based on the findings from the Phase 3 ADAPT-SC study that validated the efficacy of VYVGART Hytrulo as it showed a reduction in anti-AChR antibody levels comparable to intravenous VYVGART in adult gMG patients
US FDA Approves First Anti-Inflammatory Drug for Cardiovascular Disease
LODOCO Targets Residual Inflammation as an Underlying Cause of ASCVD and Can be Used Alone or in Combination with Cholesterol-Lowering Medications
Sirnaomics moves STP705 into late-stage trial for isSCC treatment
The FDA advised the biopharmaceutical firm to proceed with late-stage clinical development based on the efficacious data and the high prevalence of squamous cell carcinoma lesions
Health Canada approves Sun Pharma’s WINLEVI for acne treatment
In studies, a 12-week course of WINLEVI therapy decreased both inflammatory and noninflammatory lesions and significantly enhanced the proportion of patients who successfully completed treatment
SK bioscience COVID-19 Vaccine Granted Emergency Use Listing by the World Health Organization
SKYCovione is a self-assembled nanoparticle vaccine targeting the receptor binding domain of the SARS-CoV-2 Spike protein for SARS-CoV-2
Plexus Worldwide Launches Plexus Sleep
New Supplement Developed to Support Restful Sleep and a Healthy Gut Microbiome
Vaxxas opens new facility in Brisbane, Australia for HD-MAP vaccines
Spread over 60,000ft2, the custom-built Vaxxas Biomedical Facility will act as the firm’s global headquarters to scale up its operations to produce Vaxxas’ high-density microarray patches annually