Articles from Novartis Pharma AG

East Hanover, N.J., January 9, 2026 – Novartis, a leading global innovative medicines company, today announced plans to build its fourth US radioligand therapy (RLT) manufacturing facility in Winter Park, Florida. The built-for-purpose, state-of-the-art facility represents another milestone in the company's $23 billion US investment announced in April 2025, further expanding manufacturing capabilities to meet growing demand for these cutting-edge cancer treatments. Novartis is scaling US manufacturing to bring innovative medicines closer to patients, so treatments are researched, made, and delivered with greater speed, reliability, and access in the communities where people live. The new 35,000-square-foot facility in Winter Park, Florida, will come online by 2029 and will strengthen Novartis’ specialized supply chain and manufacturing capabilities across its network of RLT production facilities. The new facility will optimize the delivery of RLT medicines to patients in the southeast US and help maintain the company’s steady rate of >99% of doses administered on the planned day as the potential for this promising treatment modality continues to expand.“Building this new facility in Florida marks an important step in fulfilling the promise of RLT for patients,” said Vas Narasimhan, CEO of Novartis. “Radioligand therapy has fundamentally changed how we approach certain cancers, and our growing US manufacturing network ensures we can continue to deliver these critical medicines with speed and reliability to patients who need them.”RLT is a type of precision treatment that pairs a tumor-targeting molecule (ligand) with a therapeutic radioisotope, allowing radiation to be delivered directly to the tumor while minimizing harm to surrounding healthy tissue. Each RLT dose is individually prepared, and its delivery is highly time sensitive. Proximity to treatment facilities and transportation hubs is critical to ensure patients receive their therapy promptly and at the right location. RLT has the potential to transform oncology treatment and bring new options to people living with cancer.As the sole company with two FDA-approved RLT treatments and an extensive RLT pipeline across several tumors and targets, Novartis has global expertise in this cutting-edge technology platform that is transforming cancer care. That knowledge has fueled advancements in manufacturing techniques to build capacity and consistently deliver with confidence for patients and healthcare providers.  RLT manufacturing requires specialized talent, a key factor in determining the location for each new facility. Florida has steadily invested in higher education for life sciences and technology, helping to build the next generation of leaders critical to driving forward advanced manufacturing for platforms like RLT. With a growing skilled workforce and a regulatory and policy environment that values pharmaceutical innovation, Florida is well positioned to become a leader in pharmaceutical manufacturing. “Thanks to deliberate, focused, intensified investments and world class health innovation partnerships, we have led Florida to become a national and world-recognized leader for breakthroughs in cancer treatment, neurological innovations, and more,” said Florida Secretary of Commerce J. Alex Kelly. “Novartis’ investment in manufacturing cancer medicines here in Florida—where we’re already #2 nationally in both manufacturing for medicine and medical device technology—is an incredible opportunity to welcome world class innovators to our incredibly collaborative and impactful life sciences community.”Over the next 5 years, Novartis will solidify its robust US RLT manufacturing network. The new Florida site is the fourth of five existing or planned facilities. The company is currently investing in expansions of its RLT facilities in Indiana and New Jersey. In November, Novartis announced completion of a new RLT facility in California, and it plans to build a fifth location in the US. Novartis and radioligand therapy (RLT)Novartis is reimagining cancer care with RLT for patients with advanced cancers. By harnessing the power of targeted radiation and applying it to advanced cancers, RLT is designed to deliver treatment directly to target cells anywhere in the body.  Novartis is actively investigating the application of RLTs across cancer types and settings, with one of the deepest and most advanced pipelines in the industry, with trials in prostate cancer, breast, colon, lung, brain, pancreatic and other cancers. Novartis has established global expertise, with specialized supply chain and manufacturing capabilities across its network of RLT production sites around the world. Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release; or regarding potential future revenues from such products; or regarding discussions of strategy, plans, expectations or intentions, including discussions regarding our continued investment into new US manufacturing and R&D capabilities. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. Neither can there be any guarantee that the expected benefits from the plans and investments described in this press release will be achieved in the expected timeframe, or at all. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.Reimagine medicine with us: Visit us at https://www.novartis.us and connect with us on LinkedIn US, X/Twitter US and Instagram.

East Hanover, December 12, 2025 – Novartis, a leading global innovative medicines company, broke ground yesterday on its more than 700,000-square-foot flagship manufacturing hub in North Carolina, moving rapidly to construct its recently announced investment in the state. 

East Hanover, November 19, 2025 – Novartis, a leading global innovative medicines company, today announced plans to expand its operations in North Carolina, creating a new flagship manufacturing hub with end-to-end manufacturing capabilities. The strategic investment is a major step to ensure all key Novartis medicines for US patients are manufactured in the US and delivered to patients across the country at scale.

Basel, November 10, 2025 – Novartis, a leading global innovative medicines company, today announced the opening of a new 10,000-square-foot radioligand therapy (RLT) manufacturing facility in Carlsbad, California. This state-of-the-art site represents a key milestone in the company’s previously announced $23 billion investment in US infrastructure over the next five years.

Basel, January 5, 2024— Novartis announced today that it has received approval from the US Food and Drug Administration (FDA) for commercial manufacturing of PluvictoTM (INN: lutetium (177Lu) vipivotide tetraxetan / USAN: lutetium Lu 177 vipivotide tetraxetan) at its new large-scale, state-of-the-art radioligand therapy (RLT) manufacturing facility in Indianapolis, Indiana, United States. The 70,000-square foot site, the company’s second US location, is designed specifically for RLT manufacturing and is now the largest and most advanced Novartis facility of its kind in the world. The Indianapolis site represents the next phase of RLT manufacturing growth as this new addition brings substantial supply increases for the foreseeable future.

Basel, December 8, 2023 – Novartis today announced results from an updated invasive disease-free survival (iDFS) analysis of the pivotal Phase III NATALEE trial, with a median follow-up of 33.3 months and following Kisqali® (ribociclib) treatment completion by 78.3% of patients. Results reinforce the benefit seen at the earlier interim analysis, with a 25.1% (HR=0.749; 95% CI: 0.628, 0.892; p=0.0006) reduction in risk of disease recurrence in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) treated with adjuvant Kisqali plus a non-steroidal aromatase inhibitor as standard endocrine therapy (ET) compared to ET alone1,2. Late-breaking data from this analysis will be presented today at the 2023 San Antonio Breast Cancer Symposium (SABCS) Annual Meeting.

Ad hoc announcement pursuant to Art. 53 LR

Basel, November 20, 2023 — Novartis will present data from over 100 trials across its breast cancer and hematology portfolios at the 2023 San Antonio Breast Cancer Symposium (SABCS) and the American Society of Hematology (ASH) Annual Meeting & Exposition. The new data will highlight the latest advances across our breast cancer and hematology portfolios and pipeline, such as the Phase III NATALEE trial and Phase III APPLY-PNH trial.

Basel, March 20, 2023 — Novartis today presented new data which underscore the transformational and sustained benefit of Zolgensma® (onasemnogene abeparvovec), an essential one-time gene therapy for the treatment of spinal muscular atrophy (SMA). Latest data from two Long-Term Follow-Up (LTFU) studies, LT-001 and LT-002, show the continued efficacy and durability of Zolgensma across a range of patient populations, with an overall benefit-risk profile that remains favorable.2,3 These data are among a Zolgensma data set being presented during the 2023 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference, which also include, in part, real-world evidence data from the RESTORE registry.

Basel, March 16, 2023 — Novartis today announced the U.S. Food and Drug Administration (FDA) granted approval for Tafinlar® (dabrafenib) + Mekinist® (trametinib) for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. The FDA also approved liquid formulations of Tafinlar and Mekinist, marking the first time a BRAF/MEK inhibitor has been developed in a formulation suitable for patients as young as one year of age. These approvals make Tafinlar + Mekinist the first and only approved combination targeted therapy to treat pediatric patients with BRAF V600E LGG.