Zydus Lifesciences has signed an agreement with Myriad Genetics, a leader in molecular diagnostic testing and precision medicine company. Pursuant to the Agreement, Zydus will be introducing MyRisk� Hereditary Cancer Test, MyChoice� HRD Plus, Homologous Recombination Deficiency (HRD) Test and Prolaris� Prostate Cancer Prognostic Test to patients, clinicians, and healthcare systems across India. With the increasing incidence of cancers globally, the MyRisk� Test can help people safeguard their health and take precautionary steps and lifestyle changes that can minimise the risk of cancer. In patients suffering from prostate and ovarian cancers, the Prolaris� Test and MyChoice� HRD Plus Test, respectively, can help patients understand the disease progression and inform the right treatment path.As part of this agreement, Zydus will exclusively market, create awareness, access and engage clinicians on three of Myriad Genetics` broadly validated diagnostic platforms, MyRisk� Hereditary Cancer Test, MyChoice� HRD Plus Test for ovarian cancer, and Prolaris� a gene expression Prostate Cancer Prognostic Test. These tests have been widely adopted in the North America, Europe, and major global cancer centres, and will now empower Indian oncologists with cutting-edge genomic decision-support tools.  Powered by Capital Market - Live News

 Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences (Zydus Group), today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for copper histidinate (CUTX-101), intended to treat Menkes disease in pediatric patients. The resubmission has been accepted as a Class I response and as a result, the Company has received January 14, 2026 as the new PDUFA date. �We appreciate the Agency`s partnership and commitment to expeditiously reviewing our NDA resubmission,� said Matt Heck, CEO, Sentynl. �The acceptance of the application brings us one step closer to a milestone for patients and families who are living with Menkes disease. Sentynl resubmitted its revised NDA on 14 November 2025 after receiving a complete response letter (CRL) from the FDA on 30 September 2025, which cited observations regarding the manufacturing site`s cGMP compliance. The CRL did not cite any other approvability concerns, nor did it identify any deficiencies in CUTX-101`s efficacy and safety data, which demonstrate improvement in overall survival for Menkes disease subjects who received early treatment with the therapy. Powered by Capital Market - Live News

Zydus Lifesciences has launched `Zyrifa`, a Denosumab biosimilar. Denosumab is a monoclonal antibody with several indications related to bone health, primarily in the treatment of osteoporosis and the prevention of skeletal complications in cancer patients. This will provide access and treat patients with bone metastases due to breast, prostate, lung, myeloma, kidney, thyroid, head & neck, and other solid tumours. Metastases, is when the cancer spreads to the bones and other organs in the body indicating an advanced stage of cancer. `Zyrifa` is priced at MRP of Rs 12,495.Speaking on this launch, Dr. Sharvil P. Patel, Managing Director, Zydus Lifesciences, said �With Denosumab 120 mg SC, we aim to bring access, affordability of medication in cancer patients needing critical care. This will help patients to retain mobility, and support them in their fight against cancer�Zydus Lifesciences Limited has been launching a wide range of biosimilars to treat various cancers ranging from breast cancer to prostate cancer, various other solid tumours and blood cancer. The company has also partnered with diagnostic companies.Powered by Capital Market - Live News

Zydus Lifesciences has received the Establishment Inspection Report (EIR) from the USFDA for a GMP follow-up inspection conducted at its injectable facility located at Jarod, Vadodara from 25 August to 05 September 2025 and classifying the facility as Voluntary Action Indicated (VAI). This inspection was conducted following the Warning Letter issued on 29 August 2024 by the USFDA. Powered by Capital Market - Live News

Zydus Lifesciences has entered into an exclusive licensing and commercialization agreement with RK Pharma Inc of the US for a novel sterile injectable 505(b)(2) oncology supportive care product for the US market. Under the terms of this agreement, RK Pharma will manufacture and supply the finished product, while Zydus will be responsible for the NDA submission and commercialization of the product in the US. The product, developed under the 505(b)(2) pathway, is expected to be filed in 2026 and will provide a formulation that is intended to provide reduced dosing error and enhanced compliance of healthcare professionals.Powered by Capital Market - Live News