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Novartis (NVS) FDA Events

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FDA Events for Novartis (NVS)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Novartis (NVS). Over the past two years, Novartis has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as BIMZELX, Coartem, iptacopan, Leqvio, Lutathera, OAV101, and secukinumab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Novartis' Drugs in FDA Review

BIMZELX (bimekizumab) - FDA Regulatory Timeline and Events

BIMZELX (bimekizumab) is a drug developed by Novartis for the following indication: Moderate to Severe Plaque Psoriasis. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Coartem - FDA Regulatory Timeline and Events

Coartem is a drug developed by Novartis for the following indication: treatment for babies <5 kg with malaria. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

iptacopan - FDA Regulatory Timeline and Events

iptacopan is a drug developed by Novartis for the following indication: To treat adults with paroxysmal nocturnal hemoglobinuria (PNH). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Leqvio - FDA Regulatory Timeline and Events

Leqvio is a drug developed by Novartis for the following indication: To enable earlier use in patients with elevated LDL-C who have an increased risk of heart disease, as an adjunct to diet and statin therapy1. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Lutathera - FDA Regulatory Timeline and Events

Lutathera is a drug developed by Novartis for the following indication: s for the treatment of SSTR-positive GEP-NETs, including foregut, midgut and hindgut neuroendocrine tumors in adults and in Europe for unresectable or metastatic, progressive, well-differentiated (G1 and G2), SSTR-positive GEP-NETs in adults10-11 . This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

OAV101 IT - FDA Regulatory Timeline and Events

OAV101 IT is a drug developed by Novartis for the following indication: In Patients With Spinal Muscular Atrophy. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

secukinumab - FDA Regulatory Timeline and Events

secukinumab is a drug developed by Novartis for the following indication: In adults with newly diagnosed or relapsing giant cell arteritis (GCA). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Vanrafia® (atrasentan) - FDA Regulatory Timeline and Events

Vanrafia® (atrasentan) is a drug developed by Novartis for the following indication: In adults with primary immunoglobulin A nephropathy (IgAN). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Novartis FDA Events - Frequently Asked Questions

Yes, Novartis (NVS) has received FDA approval for Lutathera. This page tracks recent and historical FDA regulatory events related to Novartis' drug portfolio.

In the past two years, Novartis (NVS) has reported FDA regulatory activity for the following drugs: iptacopan, Leqvio, BIMZELX (bimekizumab), secukinumab, Vanrafia® (atrasentan), OAV101 IT, Coartem and Lutathera.

The most recent FDA-related event for Novartis occurred on July 3, 2025, involving secukinumab. The update was categorized as "Top-line results," with the company reporting: "Novartis announced top-line results from the Phase III GCAptAIN study evaluating Cosentyx® (secukinumab) in adults with newly diagnosed or relapsing giant cell arteritis (GCA)."

Current therapies from Novartis in review with the FDA target conditions such as:

  • To treat adults with paroxysmal nocturnal hemoglobinuria (PNH). - iptacopan
  • To enable earlier use in patients with elevated LDL-C who have an increased risk of heart disease, as an adjunct to diet and statin therapy1. - Leqvio
  • Moderate to Severe Plaque Psoriasis - BIMZELX (bimekizumab)
  • In adults with newly diagnosed or relapsing giant cell arteritis (GCA). - secukinumab
  • In adults with primary immunoglobulin A nephropathy (IgAN) - Vanrafia® (atrasentan)
  • In Patients With Spinal Muscular Atrophy - OAV101 IT
  • treatment for babies <5 kg with malaria - Coartem
  • s for the treatment of SSTR-positive GEP-NETs, including foregut, midgut and hindgut neuroendocrine tumors in adults and in Europe for unresectable or metastatic, progressive, well-differentiated (G1 and G2), SSTR-positive GEP-NETs in adults10-11 . - Lutathera

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NYSE:NVS) was last updated on 7/9/2025 by MarketBeat.com Staff
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