The conditional, time-limited approval comes through a joint effort with RACTHERA, a joint venture in which Sumitomo Chemical holds a 66.6% stake and Sumitomo Pharma holds 33.4%
Built on the Percept Platform and enhanced with BrainSense technology, the system can adjust stimulation levels in real time, responding to brain signals without manual intervention
The move follows encouraging Phase I data and a series of regulatory wins from the U.S. Food and Drug Administration
TED?A9 is part of S.Biomedics’ expanding pipeline of stem-cell-based therapies, developed using the company’s proprietary targeted embryonic stem cell differentiation platform
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Stalevo Tablets
The upcoming Phase I trial will test the safety, tolerability, and pharmacokinetics of ISM8969 in healthy volunteers and determine the optimal dosing for future studies
The RMAT designation accelerates the development of regenerative medicine therapies for serious or life-threatening diseases
The mPTP plays a key role in mitochondrial dysfunction, inflammation, and neuronal death in neurodegenerative diseases
The multicenter study will enroll 75 patients across 16 sites in Germany, Bulgaria, Poland, and Spain
The trial will evaluate the efficacy and safety of IPX203 versus immediate-release levodopa/carbidopa
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