Drug Approval | July 24, 2024
USFDA successfully inspects Carbogen Amcis’s manufacturing sites in Neuland and Aarau
The inspections concluded with no Form 483 observations or significant critical findings
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
Ulcerative Colitis (UC) is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) affecting the large intestine
Additional data from APPRAISE ATP trial reinforce modular therapy approach
Late-breaker Phase 3 STRIDE-10 trial presented as an oral presentation at European Society of Clinical Microbiology and Infectious Diseases
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