Ami informs that PMDA Japan has issued Inspection Result Report declaring the Sachin facility as a Good Manufacturing Practices (GMP) compliant.
This Fast Track Designation will enable FDA to review MM-II in an expedited manner, is an important milestone in the development of MM-II
Vonoprazan is used in the treatment of disorders related to Gastroesophageal Reflux Disease (GERD)
New Phase II data show vast majority of patients experiencing no relapses or disability progression
The new facility further improves the operational efficiency and readies the site for the completion of the new large-scale production plant
PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration
MyClad is a global Phase III study evaluating the efficacy and safety of cladribine capsules for the treatment of generalized Myasthenia Gravis (gMG)
Finerenone is the first mineralocorticoid receptor (MR) antagonist to demonstrate definitive cardiovascular benefits in a Phase III study in patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ?40%
Stressed was on the need to promote organ donation from the deceased persons to meet the huge need for organ donation in the country
The study highlighted substantial improvements in key clinical parameters among RA patients who underwent AWS intervention
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