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May 18, 2023
UK’s NICE has recommended Kapruvia as a treatment for adult patients with moderate-to-severe chronic kidney disease (CKD)-associated pruritus.
UK's NICE has recommended RINVOQ (upadacitinib) as a treatment option for adult patients in England and Wales with moderately to severely active Crohn’s disease.
May 17, 2023
The agency’s safety committee is reviewing hydroxyprogesterone medicines and issuing a reminder on safety issues regarding fluoroquinolone antibiotics.
The agency has published guidance on good practices for securing the supply of medicines.
The report outlines highlights from the agency’s medicines evaluations and milestones for 2022.
May 11, 2023
EC has granted marketing authorization to Chiesi Global Rare Diseases and Protalix BioTherapeutics for PRX-102 (pegunigalsidase alfa).
May 10, 2023
EMA and European regulators are lifting their COVID-19 business continuity measures as the pandemic’s peak ends.
May 02, 2023
Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.
April 02, 2023
Proposed regulatory changes signal a major overhaul of legislation governing pharmaceuticals and healthcare in Spain.
March 15, 2023
The impact of the potential ban would have serious consequences for the availability of many drugs for European patients.