Apellis Pharmaceuticals has announced US FDA acceptance of the supplemental new drug application (sNDA) and the granting of ...

Sanofi (NASDAQ:SNY) said on Tuesday that the US FDA has granted priority review to the regulatory submission of tolebrutinib for the treatment of multiple sclerosis. Tolebrutinib, a treatment under ...

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

The supplemental New Drug Application for the C3G and IC-MPGN indications is supported by data from the phase 3 VALIANT study.

(RTTNews) - Apellis Pharmaceuticals, Inc. (APLS) Tuesday said that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the supplemental New Drug Application ...

Catalyst Pharmaceuticals (CPRX) reported that its sub-licensee in Canada, Kye Pharmaceuticals, has announced that Health Canada has accepted ...

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 ...

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