USFDA seeks more analysis on Merck’s BLA for Vaxneuvance
No new studies have been requested
No new studies have been requested
It paves the way for an industry Code of Good Practice
A major unresolved question in the field, however, is how do this machinery rapidly searches for and finds rare stretches of damage amid the "vast fields" of undamaged DNA
The valve has a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve
The summit also saw the launch of two important reports- Multi-Regional Clinical Trials (MRCT) and Value of OTC in India
Ondexxya is the first approved reversal agent specifically for Factor Xa inhibitors, providing a major advance in the treatment of patients hospitalised with life-threatening bleeding
India accounts for more than half (almost 60%) of new leprosy cases worldwide, despite being declared ‘leprosy-free’ in 2005.
Companies to leverage proprietary IgM antibody technology platform to discover agonists against three oncology targets and three immunology/inflammation targets
Vortioxetine is a novel antidepressant with multimodal activity, which is approved to treat Major Depressive Disorder (MDD) in adults
Approval is based on results of a multicenter, randomized, open-labeled and controlled IDE clinical study that demonstrated the superiority of Agili-C™ implant to the current surgical standard of care, debridement and microfracture in the knee joint
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