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.

Q4 2024 Management View CEO Linda Marban highlighted the acceptance by the FDA of Capricor's Biologics License Application (BLA) for deramiocel, targeting treatment of Duchenne muscular dystrophy (DMD ...

The FDA will review the application under priority review and has assigned a PDUFA target action date of September 22, 2025. The company has also submitted and received validation for Marketing ...

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 ...

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 ...

Regulators are expected to make a decision in the third quarter of 2025 on Kerendia to treat patients with heart failure with ...

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 ...

The application has been granted priority review with a PDUFA date set for August 31, 2025. The BLA submission is supported by data from the Phase 2 HOPE-2 and HOPE-2 open-label extension trials ...