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Goodwin

Regulatory Updates on Samsung’s Denosumab Biosimilars

Goodwin on

On February 13, 2025, the FDA approved Samsung Bioepis Co., Ltd.’s denosumab biosimilars, OSPOMYV™ (denosumab-dssb; 60 mg pre-filled syringe) and XBRYK™ (denosumab-dssb; 120 mg vial), referencing Amgen’s PROLIA® and XGEVA®,...more

Lippes Mathias LLP

Hospital Administrators – Is Your Hospital Cyber-Secure?

Lippes Mathias LLP on

On October 2, 2024, New York adopted new regulations requiring general hospitals to implement heightened cybersecurity safeguards. General hospitals, as defined in Article 28 of the NY Public Health Law, generally must begin...more

Health Care Compliance Association (HCCA)

Compliance Today - December 2022. Intersection of ESG, health equity, and 501(r) compliance

Compliance Today - December 2022 - We are at a critical moment of change when it comes to truly addressing health inequities in this country. With the intersection of environmental, social, and governance (ESG) reporting and...more

Franczek P.C.

HHS Issues Final Rule on ACA Nondiscrimination in Health Programs and Activities

Franczek P.C. on

On May 18, 2016, the Department of Health and Human Services (“HHS”) issued final regulations interpreting the nondiscrimination provisions of Section 1557 of the Affordable Care Act (“ACA”). The rule mainly impacts insurers...more

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