Amneal and mAbxience score FDA green light for two Denosumab biosimilars

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

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

NUFYMCO BLA has been approved by the USFDA

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

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

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

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

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

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