The FDA has accepted for Priority Review the BLA for apitegromab for the improvement of motor function in patients with spinal muscular atrophy.

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

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.

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

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

Tolebrutinib is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory ...

A Prescription Drug User Fee Act target date of September 22, 2025 has been set for the application. The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License ...

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 ...

Finerenone was associated with a 16% reduction for the primary composite endpoint of cardiovascular death and total HF events compared with placebo. The Food and Drug Administration (FDA) has ...

Regulators are expected to make a decision in the third quarter of 2025 on Kerendia to treat patients with heart failure with a left ventricular ejection fraction (LVEF) of ≥40%.