FDA completes inspection of SMS Pharma’s Vizag facility
The inspection concluded with one minor observation in Form 483
The inspection concluded with one minor observation in Form 483
The company will respond to the US FDA within the stipulated timelines
The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies
Columvi combined with gemcitabine and oxaliplatin dramatically extends survival in people with relapsed or refractory diffuse large B-cell lymphoma
MRI is particularly valuable in pediatric care due to its non-invasive nature
The company is excluding data from the affected sites to maintain the study's integrity
It's a development that marks a major step forward for patients struggling with moderate-to-severe chronic spontaneous urticaria
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