The updated label no longer requires Leqvio (inclisiran) to be used in combination with statins for low-density lipoprotein ...

Novartis announced today that the US Food and Drug Administration (FDA) has approved a label update for Leqvio® (inclisiran), enabling its use as monotherapy along with diet and exercise to reduce low ...

The update was requested by the FDA based on data supporting the significant LDL-C lowering abilities of PCSK-targeting therapies.

Novartis has obtained global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals, a leader in RNAi therapeutics.

The pharmaceutical company raised its full-year profit guidance as ongoing demand for key drugs fueled growth in second-quarter sales and earnings.

EAST HANOVER, N.J., July 10, 2023 /PRNewswire/ -- Novartis announced today that the US Food and Drug Administration (FDA) has approved a label update for Leqvio® (inclisiran) to enable earlier ...

Novartis announced positive Phase 3 V-MONO study results for Leqvio, showing significant LDL-C reduction in low and moderate ASCVD risk patients, as the company continues to explore its potential ...

In its Q2 earnings call Thursday, Novartis said it is moving quickly to reshore its drug manufacturing operations, but CEO ...

Basel, December 22, 2021 — Novartis today announced the US Food and Drug Administration (FDA) approval of Leqvio® (inclisiran), the first and only small interfering RNA (siRNA) therapy to lower ...

Wednesday, Novartis AG (NYSE:NVS) released topline results from twice-yearly Leqvio (inclisiran) in the Phase 3 V-MONO study, which met its primary endpoints. V-MONO is part of the 60,000-patient ...