The New Drug Application (NDA) includes data from the Phase III studies OASIS 1, 2 and 3 - showing elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms over 12 weeks compared to placebo
Report highlights significant improvements in adolescent well-being in India
The discussion at the fourth session was centered on the fusion of academic rigor and industrial pragmatism as a key to pioneering solutions for sustainable and prosperous future
The inspections concluded with no Form 483 observations or significant critical findings
Findings from the SEIMC-GeSIDA Foundation (FSG) PASO-DOBLE study will include treatment efficacy, safety, and weight gain
GL0034 administered once-weekly confirmed clinically meaningful weight loss and improved glucometabolic parameters over a 4-week treatment period in individuals with obesity
The company will now explore a buyer for its manufacturing site and exit in due course
PICCOLO trial met its primary endpoint of objective response rate (ORR)
Updated analysis from Memorial Sloan Kettering Cancer Center presented at ASCO 2024 has expanded to 42 patients with clinical complete response
The companies have initiated Phase 3 studies in patients with high-risk melanoma and non-small cell lung cancer
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