Shilpa Medicare aims for US approval of chemo nausea drug
Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections
Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections
The PRIOH-1 study met its primary endpoint, delivering statistically significant and clinically meaningful improvements in lesion healing
Venglustat, a glucosylceramide synthase inhibitor (GCSi), works by reducing the abnormal buildup of sugar-and-fat molecules in cells and organs
The study tested whether PF’3944 could maintain efficacy when switching from weekly to monthly injections and remain safe and well-tolerated
The trial supports the potential for another chemotherapy backbone option that may be paired with encorafenib plus cetuximab in this patient population
This is the first controlled pharmacologic study to demonstrate that treatment of obesity improved PsA disease measures
REDEMPLO is the first and only Health Canada-approved siRNA therapy for FCS
The company is pursuing the accelerated FDA 505(b)(2) approval pathway for its once-daily oral ondansetron formulation
Valneva said regaining full rights to the vaccine will allow the company to “assume direct control over its supply chain and commercialization for endemic high-risk countries
The approval is supported by data from three pivotal clinical trials
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