Novartis — Pharmaceutical Intelligence | Humanexa Signals

ClinicalJuly 10, 2026

Novartis initiates study on Alpelisib and Fulvestrant for advanced HR+ breast cancer

Novartis is conducting a study to evaluate the efficacy and safety of alpelisib plus fulvestrant in HR-positive, HER2-negative advanced breast cancer patients who have progressed after prior treatments.

Recent signals(42)

FDA Accepts Supplemental NDA for Mekinist by Novartis

FDA Accepts Supplement for Pluvicto (Lutetium Lu-177) by Novartis

FDA Approves Lutetium Lu 177 VIPIVOTIDE for Metastatic Prostate Cancer

FDA Approves Supplemental Application for MYFORTIC by Novartis

Novartis initiates Phase Ib/II study of AMO959 in mCRPC with AAA617 and ARPI

FDA Submission Update for COSENTYX (Secukinumab) by Novartis

FDA Grants Priority Review for Cosentyx Supplement Application

Novartis initiates Phase I/II trial for ERW316 in HR+/HER2- breast cancer

Novartis initiates long-term safety study for ruxolitinib and panobinostat combination

Novartis initiates study on DII235 for elevated lipoprotein(a)

FDA Grants Priority Review for Novartis' Fabhalta (Ipacopan Hydrochloride)

FDA Accepts Supplement Application for GLEEVEC (Imatinib Mesylate)

FDA Acceptance of Supplement for AFINITOR (Everolimus) by Novartis

FDA Accepts Supplement Application for Sandimmune by Novartis

FDA Approves Supplement for Tegretol (Carbamazepine) by Novartis

Novartis Fabhalta® (iptacopan) gains FDA approval for primary IgAN treatment

Novartis initiates real-world study on Pluvicto in metastatic CRPC patients

FDA Accepts Supplement for Gleevec (Imatinib Mesylate) by Novartis

Novartis initiates Phase III trial of Atrasentan in pediatric IgAN patients

Novartis Evaluates Remibrutinib for Secondary Progressive Multiple Sclerosis

FDA Accepts Supplement for Mekinist (Trametinib) by Novartis

Novartis initiates long-term follow-up study for OAV101 in Spinal Muscular Atrophy

Novartis initiates Phase II trial of MAS825 for Still's Disease

Novartis initiates tolerability study of ianalumab with TPO-RA in ITP patients

FDA Grants Priority Review for KISQALI FEMARA Co-Packaged Product

Novartis initiates study on Alpelisib and Fulvestrant for advanced HR+ breast cancer

FDA Grants Priority Review for KISQALI Supplement by Novartis

FDA Accepts Supplemental Application for MAYZENT (Siponimod) by Novartis

Novartis initiates ascending dose study of PIT565 for rheumatoid arthritis

FDA Approves Supplemental Application for Cosentyx (Secukinumab)

Novartis initiates trial for JDQ443 in KRAS G12C-mutated NSCLC

Novartis initiates pediatric study for asciminib in Chronic Myeloid Leukemia

Novartis initiates Phase I/II study of YTB323 in non-active Progressive Multiple Sclerosis

Novartis initiates Phase I/II trial of YTB323 for treatment-resistant generalized myasthenia gravis

Novartis initiates pediatric long-term follow-up study for dabrafenib and trametinib

Novartis conducts safety study of Iptacopan in PNH patients using registry data

Novartis initiates trial for inclisiran in acute coronary syndromes

First-in-human study of NTSR1-targeted imaging in prostate cancer shows promise

Dabrafenib and Trametinib Rollover Study for Continued Patient Access

Feasibility Study on Sensory Changes in Pediatric Oncology Patients Undergoing Treatment

R-MVST Cells Show Promise for Treating Refractory Viral Infections

Novel Pra-peptide hydrogel shows promise for treating ocular inflammation

Upcoming catalysts

Regulatory activity(18)

FDA Accepts Supplemental NDA for Mekinist by Novartis

FDA Accepts Supplement for Pluvicto (Lutetium Lu-177) by Novartis

FDA Approves Lutetium Lu 177 VIPIVOTIDE for Metastatic Prostate Cancer

FDA Approves Supplemental Application for MYFORTIC by Novartis

FDA Submission Update for COSENTYX (Secukinumab) by Novartis

FDA Grants Priority Review for Cosentyx Supplement Application

FDA Grants Priority Review for Novartis' Fabhalta (Ipacopan Hydrochloride)

FDA Accepts Supplement Application for GLEEVEC (Imatinib Mesylate)

FDA Acceptance of Supplement for AFINITOR (Everolimus) by Novartis

FDA Accepts Supplement Application for Sandimmune by Novartis

FDA Approves Supplement for Tegretol (Carbamazepine) by Novartis

Novartis Fabhalta® (iptacopan) gains FDA approval for primary IgAN treatment

FDA Accepts Supplement for Gleevec (Imatinib Mesylate) by Novartis

FDA Accepts Supplement for Mekinist (Trametinib) by Novartis

FDA Grants Priority Review for KISQALI FEMARA Co-Packaged Product

FDA Grants Priority Review for KISQALI Supplement by Novartis

FDA Accepts Supplemental Application for MAYZENT (Siponimod) by Novartis

FDA Approves Supplemental Application for Cosentyx (Secukinumab)

Clinical activity(22)

Novartis initiates Phase Ib/II study of AMO959 in mCRPC with AAA617 and ARPI

Novartis initiates Phase I/II trial for ERW316 in HR+/HER2- breast cancer

Novartis initiates long-term safety study for ruxolitinib and panobinostat combination

Novartis initiates study on DII235 for elevated lipoprotein(a)

Novartis initiates real-world study on Pluvicto in metastatic CRPC patients

Novartis initiates Phase III trial of Atrasentan in pediatric IgAN patients

Novartis Evaluates Remibrutinib for Secondary Progressive Multiple Sclerosis

Novartis initiates long-term follow-up study for OAV101 in Spinal Muscular Atrophy

Novartis initiates Phase II trial of MAS825 for Still's Disease

Novartis initiates tolerability study of ianalumab with TPO-RA in ITP patients

Novartis initiates study on Alpelisib and Fulvestrant for advanced HR+ breast cancer

Novartis initiates ascending dose study of PIT565 for rheumatoid arthritis

Novartis initiates trial for JDQ443 in KRAS G12C-mutated NSCLC

Novartis initiates pediatric study for asciminib in Chronic Myeloid Leukemia

Novartis initiates Phase I/II study of YTB323 in non-active Progressive Multiple Sclerosis

Novartis initiates Phase I/II trial of YTB323 for treatment-resistant generalized myasthenia gravis