A decision on tolebrutinib for treating MS is now set for Sept. 28, after the FDA granted priority review to its approval ...
Sanofi (NASDAQ:SNY) said on Tuesday that the US FDA has granted priority review to the regulatory submission of tolebrutinib ...
A Prescription Drug User Fee Act (PDUFA) target action date for apitegromab has been set for Sept. 22, 2025.
Apitegromab, a fully human monoclonal antibody, works by selectively binding to the pro- and latent forms of myostatin in order to inhibit myostatin activation.
A Prescription Drug User Fee target date of September 28, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug ...
The US Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS ...
Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis If approved, tolebrutinib would be the first and only brain-penetrant BTK inhibitor to ...
Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis If approved, tolebrutinib would be the first and only brain-penetrant BTK inhibitor to ...
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