<p>The rapid expansion of large-scale pharmacy compounding has outpaced existing regulatory frameworks, prompting bipartisan legislative action in the United States Senate. The Safeguarding ...

<p>On 25 September 2026, the US Food and Drug Administration (FDA) approved Teva Pharmaceuticals’ Degevma (denosumab-adet), a biosimilar to Amgen’s Xgeva (denosumab) [1].</p>

<p>Swissmedic has revised its Guidance document Authorisation Biosimilar to align with the European Medicines Agency’s (EMA) finalised reflection paper on a tailored clinical approach in ...

<p>The US Food and Drug Administration (FDA) has issued a draft strategy document titled ‘BsUFA III Future Needs in the Development of Interchangeable Products Post-Workshop Strategy Document’, ...

<p>On 17 September 2026, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending marketing authorisation for two ...