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Oct 62 min read

EMA Guideline: Quality and Equivalence of Locally Applied, Locally Acting Cutaneous Products

The European Medicines Agency (EMA) recently updated the guideline on "Quality and Equivalence of Locally Applied, Locally Acting...

Jul 152 min read

New EU Regulations on AI in Medical Devices: Key Insights and Implications

The European Union has published the finalized text of the Artificial Intelligence Act (AIA) which is a significant step forward in...

Aug 24, 20221 min read

Gilead: First Regulatory Approval of HIV Sunlenca® (Lenacapavir) the Only Twice-Yearly HIV Treatment

On 22-August-2022, Sunlenca (lenacapavir) is an injectable HIV medication developed by Gilead Sciences that has been approved to market...