Drug Approval | January 23, 2024
EMA grants ODD to GC Biopharma's treatment for Sanfilippo Syndrome
GC1130A has previously achieved notable milestones by securing both RPDD and ODD from the U.S. FDA in January 2023
GC1130A has previously achieved notable milestones by securing both RPDD and ODD from the U.S. FDA in January 2023
The orphan drug designation by the EC is issued for drugs which are intended to treat diseases that affect fewer than five in 10,000 people in the European Union
If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients
V116 is an investigational, 21-valent pneumococcal conjugate vaccine specifically designed to protect adults
The booster vaccine can be administered safely to individuals who have received two doses of either Covaxin or Covishield
Upon approval, XPHOZAH would be the first and only phosphate absorption inhibitor, offering patients a novel mechanism
If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers
This will be an added advantage for Supriya Lifescience Limited in the European market.
The Bulk Drug Parks to be developed under the scheme will provide common infrastructure facilities at one place thereby creating a robust ecosystem for the bulk drug manufacturing in the country and also reducing manufacturing cost significantly
75 inter-disciplinary, multi-institutional grants would be supported for high-risk, ambitious research ideas, milestones-driven collaborative research in all domain areas of the biotech sector
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