Drug Approval | December 13, 2022
European Commission approves SPEVIGO for generalized pustular psoriasis flares
EC grants conditional marketing authorization based on the EFFISAYIL trial
EC grants conditional marketing authorization based on the EFFISAYIL trial
First and only next-generation protein-based adjuvanted COVID-19 booster approved in Europe
This Keytruda combination is the first immunotherapy option approved in the EU for high-risk early-stage TNBC
Ulcerative colitis is a chronic, immune-mediated inflammatory bowel disease that can lead to substantial burden and often disability among patients
First approved therapy in Europe for the treatment of chronic kidney disease (CKD)-associated pruritus in hemodialysis patients
KEYTRUDA is now approved as monotherapy for adults with Renal Cell Carcinoma (RCC)
Gavreto is the first and only precision medicine approved in the EU for first-line treatment of people with RET fusion-positive advanced NSCLC
The European Commission (EC) granted marketing authorisation for Celltrion’s regdanvimab following a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) last week
Data demonstrates Ronapreve reduced risk of hospitalisation in certain patients and reduced risk of symptomatic Covid-19 infections in people exposed to the virus
It is estimated that over 11,000 children across Europe, Middle East, and Africa are affected by achondroplasia and could be eligible for treatment with Voxzogo
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