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%
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 RMAT designation accelerates the development of regenerative medicine therapies for serious or life-threatening diseases
ALTO-207 combines pramipexole, a dopamine D3-preferring D3/D2 agonist approved for Parkinson’s disease
NTX-253 is a potent, selective, orally available positive allosteric modulator (PAM) of the muscarinic M4 receptor
Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor
Cobenfy generated $43 million in third-quarter sales, up from $35 million in the second quarter
Investigational cell therapy bemdaneprocel continues to demonstrate a favorable safety profile at 36 months in Phase I trial participants
If approved, tavapadon will enhance AbbVie's leadership in Parkinson's disease by providing patients with a once daily oral treatment option
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