Regulatory Affairs

Showing 3 posts of 3 posts found.

GSK’s Exdensur receives MHRA approval for asthma and rhinosinusitis

December 16, 2025 Regulatory Affairs, Research and Development Asthma & COPD, GSK

GSK’s Exdensur (depemokimab), a twice-yearly biological medicine, has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) …
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CSL Behring’s angioedema treatments receives NICE recommendation

September 26, 2025 Regulatory Affairs, Research and Development Andembry, CSL Behring, hereditary angioedema

The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending CSL Behring’s ANDEMBRY (garadacimab) for …

EU regulatory momentum could catalyse clinical trial innovation

June 5, 2025 Regulatory Affairs, Research and Development AI, Corporate, EU regulation, Hospital Management, Pharmacy, Veeva Systems

Dr Werner Engelbrecht at Veeva Systems discusses how compliance can be turned into a competitive advantage with connected platforms and …
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