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Results For "BLA"

352 News Found

Hansa Biopharma submits FDA application for kidney transplant desensitization treatment
News | December 24, 2025

Hansa Biopharma submits FDA application for kidney transplant desensitization treatment

If approved, imlifidase has the potential to transform the kidney transplant landscape by enabling highly sensitized patients to also have access to a potentially life-changing kidney transplant


Abbott’s Volt PFA System gets FDA nod
News | December 24, 2025

Abbott’s Volt PFA System gets FDA nod

AFib is a progressive condition where timely intervention is critical to disease management and, ultimately, the patient's quality of life


Zydus Partners with Bioeq for US commercialisation rights for Nufymco
News | December 23, 2025

Zydus Partners with Bioeq for US commercialisation rights for Nufymco

NUFYMCO BLA has been approved by the USFDA


FDA nod to MYQORZO for obstructive hypertrophic cardiomyopathy
Drug Approval | December 23, 2025

FDA nod to MYQORZO for obstructive hypertrophic cardiomyopathy

The drug is designed to improve functional capacity and reduce symptoms by inhibiting cardiac myosin motor activity


Vanda Pharmaceuticals seeks FDA nod for breakthrough psoriasis drug
Drug Approval | December 17, 2025

Vanda Pharmaceuticals seeks FDA nod for breakthrough psoriasis drug

Imsidolimab, an IgG4 IL-36 receptor antagonist, works by inhibiting IL-36 receptor signaling, directly addressing the deficiency in the IL-36RA regulator common in GPP patients


Zydus and Formycon secure US and Canada partnership for Keytruda biosimilar
News | December 10, 2025

Zydus and Formycon secure US and Canada partnership for Keytruda biosimilar

Formycon AG will develop, register, manufacture and supply the product, while Zydus Lifesciences Global FZE, United Arab Emirates will be responsible for the commercialization of FYB206 in the defined territories


OSR Holdings moves towards major licensing deal for oral cancer immunotherapy
Healthcare | December 01, 2025

OSR Holdings moves towards major licensing deal for oral cancer immunotherapy

Under the proposed terms, Vaximm would secure a $20 million upfront payment, up to $815 million tied to clinical, regulatory, and commercial milestones


Investors pile in as Cordance secures oversubscribed seed round for brain-cancer tech
News | November 27, 2025

Investors pile in as Cordance secures oversubscribed seed round for brain-cancer tech

The fresh capital will propel Cordance into its first-in-human clinical trial


Cidara hits target enrollment for Phase 3 flu trial ahead of peak season
Clinical Trials | November 27, 2025

Cidara hits target enrollment for Phase 3 flu trial ahead of peak season

CD388 is administered as a single 450-milligram subcutaneous dose in adults and adolescents


NHS’s breakthrough leukaemia therapy set to transform lives in UK
Clinical Trials | November 27, 2025

NHS’s breakthrough leukaemia therapy set to transform lives in UK

Clinical trials found that 77% of patients went into remission after receiving obe-cel