emjreviews.com6h
EU Rejects Majority of US Fast-Tracked Cancer Drugs
A new study reveals that more than half of cancer drugs approved by the FDA under accelerated pathways are not authorized in ...
pharmaphorum2d
European Medicines Agency reveals favoured cities for relocation
The European Medicines Agency has revealed a list of five cities that are preferred as its new location by staff after Brexit, following warnings of a public health disaster if EU leaders pick ...
European Medicines Agency Confirms Acceptance of Marketing Authorization Application for AVT05, a Proposed Biosimilar to Simponi® (golimumab)
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for ...
Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer’s Disease
1. About lecanemab (generic name, brand name: Leqembi®) Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal ...
Benzinga.com29d
European Medicines Agency's Panel Supports Approval Of Novartis' Kisqali In Patients With Early-Breast Cancer
The European Commission (EC) will decide in approximately two months. Last month, Novartis released new data from the ALITHIOS open-label extension study. Data show first-line Kesimpta (ofatumumab ...
FiercePharma23h
EU regulators endorse meds from BMS, J&J, Eisai and more—plus a clutch of biosims
Now, it's up to the European Commission to confirm those potential green lights in the coming weeks and months.
Sandoz receives European Commission approval for Afqlir® (aflibercept), further strengthening leading biosimilar portfolio
MEDIA RELEASEAfqlir® (aflibercept) approved to treat various retinal diseases, including neovascular age-related macular degeneration (nAMD)One ...