European Union
Radiesse approval expands in European Union to treat wrinkles in décolleté area
Radiesse has been approved in the European Union to treat wrinkles in the décolleté area, Merz Aesthetics announced in a press release.
EMA accepts marketing authorization for bimekizumab for hidradenitis suppurativa
The European Medicines Agency has accepted for review the marketing authorization application for bimekizumab for moderate to severe hidradenitis suppurativa treatment in adults, UCB announced in a press release.
Akebia receives European approval for anemia drug
Akebia Therapeutics Inc. has received approval from the European Commission to market its oral hypoxia-inducible factor prolyl hydroxylase inhibitor Vafseo in Europe, according to a press release.
European Medicines Agency recommends bimekizumab in two new indications
The European Medicines Agency has recommended granting marketing authorization for bimekizumab for the treatment of adults with axial spondyloarthritis and active psoriatic arthritis, according to a UCB press release.
European Medicines Agency recommends Cosentyx for adults with hidradenitis suppurativa
The European Medicines Agency has issued a positive opinion of Cosentyx for the treatment of adults with moderate to severe hidradenitis suppurativa and recommends a marketing authorization be granted, Novartis announced in a release.
European Commission approves Opzelura for adults, adolescents with nonsegmental vitiligo
The European Commission has approved Opzelura in the European Union to treat nonsegmental vitiligo with facial involvement in patients aged 12 years and older, Incyte announced in a press release.
European Commission approves Sotyktu for adults with moderate to severe plaque psoriasis
The European Commission has approved Sotyktu in the European Union for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, Bristol Myers Squibb announced in a press release.
European Commission grants second orphan drug designation for TMB-001
The European Commission has granted orphan drug designation for TMB-001 for the treatment of X-linked recessive ichthyosis, Timber Pharmaceuticals announced in a press release.
Almirall reports core net sales growth in 2022 financial results
Almirall announced its financial results for 2022, which included a core net sales growth of 6.6% driven by its European sales, according to a company press release.
European Commission approves Dupixent, first targeted treatment for prurigo nodularis
The European Commission has approved Dupixent for the treatment of moderate to severe prurigo nodularis in adults who are candidates for systemic therapy in the European Union, Regeneron and Sanofi announced in a press release.