Unichem receives Form 483 from USFDA with 3 observations for Roha API facility
The company will provide the necessary response to USFDA within stipulated 15 days
The company will provide the necessary response to USFDA within stipulated 15 days
Pivotal phase III SUNMO study demonstrated an 11.5 month median progression-free survival - three times longer than R-GemOx
Prasinezumab is a potential first-in-class anti-alpha-synuclein antibody, targeting a known biological driver of Parkinson’s disease progression
46% reduction in the risk of disease progression or death, and 27% reduction in the risk of death, in an aggressive cancer type with limited survival and few treatment options
If approved, linerixibat could address high unmet medical need of patients living with cholestatic pruritus (relentless itch) and related sleep interference
Simplified storage and administration of new tablet formulation may provide greater freedom and independence for people with Spinal Muscular Atrophy (SMA)
BioNTech and Bristol Myers Squibb will jointly execute a broad clinical development program to evaluate and advance BNT327 across numerous solid tumor types
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