Italian pharma major Recordati (RECI: MI) today announced that the US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Isturisa (osilodrostat) for the ...

Apellis Pharmaceuticals APLS announced that the FDA has accepted its supplemental new drug application (sNDA) seeking the label expansion of Empaveli (pegcetacoplan) for two rare and severe kidney ...

Travere Therapeutics has submitted a supplemental New Drug Application (sNDA) to the FDA for FILSPARI (sparsentan) as a priority review for the treatment of focal segmental glomerulosclerosis ...

The Company expects to receive notice regarding the acceptance for review of the sNDA submission as well as the timeline for sNDA review from the FDA in the second quarter of 2025. Additionally ...

Bayer AG BAYRY recently announced that the FDA had accepted its supplemental new drug application (sNDA) seeking approval for Kerendia (finerenone) to treat a new indication. The sNDA seeks ...