Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections
Approval is based on results from the phase 3 OASIS 4 clinical trial
The results confirm the study’s primary endpoint of objective response rate and now deliver a striking signal in progression-free survival
BPDCN typically presents with skin lesions before rapidly spreading to the bone marrow, lymph nodes
The company is expected to conduct further studies to confirm the long-term efficacy and safety of Vijoice in both adult and paediatric patients
The company said all doses achieved statistically significant reductions in body weight compared with placebo at 72 weeks
The twin designations are designed to speed up the development and review of promising medicines targeting serious conditions with high unmet need
Advisory from Apollo Spectra Hospitals highlights hydration, nutrition, and screening as key preventive measures
The trial also demonstrated significant improvements across multiple secondary endpoints
They also differentiated the innovator biologic Semaglutide molecule from newer synthetic or chemical generic versions entering the market
Subscribe To Our Newsletter & Stay Updated
_256_275.jpeg)
