Zydus Lifesciences

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Zydus Life's US arm gets FDA nod for Menkes disease drug resubmission

The drug, CUTX-101, is intended for the treatment of Menkes disease, a rare X-linked recessive genetic disorder affecting male children

Zydus Lifesciences introduces biosimilar for cancer patients' bone health

Zydus Lifesciences on Wednesday said it has launched a biosimilar for the treatment of osteoporosis and the prevention of skeletal complications in cancer patients. The company 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, the Ahmedabad-based drug firm said in a regulatory filing. Metastases, is when the cancer spreads to the bones and other organs in the body indicating an advanced stage of cancer. The company said it has priced 'Zyrifa' at MRP of Rs 12,495. Sharvil P Patel, Managing Director, Zydus Lifesciences Ltd said that with Denosumab 120 mg SC, the company aims to bring access, affordability of medication in cancer patients ...

Zydus Lifesciences shares rise 2% on expanding its biosimilar portfolio

Zydus Lifesciences shares rose 2 per cent on Wednesday after it announced two key developments aimed at expanding its biosimilar portfolio

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Zydus and Formycon ink licensing agreement for biosimilar in US, Canada

Zydus will commercialise FYB206 in North America, while Formycon will lead development, regulatory filings and supply, with a US FDA filing expected soon

Zydus Lifesciences, RK Pharma sign deal for licensing, commercialisation

Zydus Lifesciences Ltd on Wednesday said it has entered into an exclusive licensing and commercialisation agreement with RK Pharma Inc of the US for a new sterile injectable 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 (new drug application) submission and commercialisation of the product in the US, the company said in a regulatory filing. The product 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, it added. "This partnership reinforces our commitment to delivering high-quality, affordable medicines and improving patient care," Zydus Lifesciences Managing Director Sharvil Patel said. RK Pharma Founder and Executive Chairman Ravishanker Kovi said, "Our collaboration with Zydus, a company with robust regulatory expertise and

Zydus Lifesciences shares rise after USFDA nod, RK Pharma licensing deal

Zydus Lifesciences gained 2 per cent after securing USFDA approval for Verapamil ER tablets and signing an exclusive deal with RK Pharma

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Neuland, Lupin, Divi's lead domestic, CDMO surge amid US generics headwinds

Analysts noted that while US generics face margin headwinds, domestic formulations and CDMOs remain resilient. Biosimilars are also poised for growth through new launches and regulatory support.

Zydus Lifesciences marks China entry with approval for antidepressant drug

Indian drug cos Chinese pipelines start getting regulator nod; Glenmark got nod for nasal spray this week

Zydus Life Q2: Solid beat on bottom line, analysts mixed on growth outlook

Zydus Life Q2 results review: Foreign brokerage Nomura said Zydus Life delivered results above estimates, led by a stronger-than-expected performance in India.

Zydus PAT up 38% on strong India, US growth; board okays ₹5K cr fundraise

Zydus Lifesciences reported a 17% YoY rise in revenue to Rs 6,123 crore and a 38% jump in profit to Rs 1,258.6 crore in Q2 FY26, driven by India and US formulations performance

Zydus gets USFDA's orphan drug designation for beta-thalassemia product

Zydus Lifesciences on Thursday said the US health regulator has granted Orphan Drug Designation (ODD) to Desidustat, a novel product for the treatment of beta-thalassemia. The US Food and Drug Administration (USFDA) grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 2 lakh people in the US. "This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop Desidustat to address beta-thalassemia," Zydus Lifesciences MD Sharvil Patel said in a regulatory filing. Beta thalassaemia patients have low levels of haemoglobin, which results in a lack of oxygen in many parts of the body, leading to weakness, fatigue and more serious complications. Treatment for people with beta thalassaemia often requires lifelong regimens of chronic blood transfusions for survival and treatment for iron overload due to the transfusions. Desidustat is a hypoxia inducible factor (HIF)-prolyl hydroxylase inhibitor (PHI) an

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IPA appoints Zydus Lifesciences MD Sharvil Patel as new President

Sharvil Patel takes over as President of IPA from Samir Mehta, with Glenn Saldanha appointed Vice President, as the industry navigates reforms and global challenges

Zydus Lifesciences growth aided by acquisitions, but execution risks loom

Zydus Lifesciences trades near 52-week highs on strong growth and acquisitions but analysts caution that rapid expansion and diversification may pose execution challenges

ICMR licences multi-stage malaria vaccine 'AdFalciVax' to five companies

The selection of companies was made through an Expression of Interest (EoI) process launched by ICMR in July

Zydus Lifesciences' Q1 dose lifts vitals, but outlook stays fragile

April-June Qtr beat offsets some caution, yet US headwinds cap upside