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

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

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 ...

The FDA accepts Apellis' sNDA seeking label expansion of Empaveli to treat two rare kidney diseases for review under the Priority Review pathway.

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

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

Kye Pharmaceuticals announced it has submitted a New Drug Submission, or NDS, to Health Canada for the regulatory review and approval of ...

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

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 ...

(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 ...