A decision on tolebrutinib for treating MS is now set for Sept. 28, after the FDA granted priority review to its approval ...

A Prescription Drug User Fee Act (PDUFA) target action date for apitegromab has been set for Sept. 22, 2025.

Sanofi (NASDAQ:SNY) said on Tuesday that the US FDA has granted priority review to the regulatory submission of tolebrutinib ...

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 U.S. Food and Drug Administration is evaluating under priority review the regulatory submission of tolebrutinib to treat non-relapsing ...

FDA grants Priority Review status to Sanofi's tolebrutinib for the treatment of non-relapsing secondary progressive multiple ...

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 ...

The FDA has accepted for Priority Review the sNDA for finerenone for heart failure with mildly reduced or preserved ejection fraction.

A Prescription Drug User Fee Act target date of August 27, 2025 has been set for the application. The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License ...

I'm happy to report that not only did it complete the rolling BLA submission of Deramiocel, but the FDA accepted the regulatory application with Priority Review with a PDUFA target action date of ...

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 ...