FiercePharma3d
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.
EU health agency urges stepped-up antibiotic resistance fight
The European Union health agency on Monday warned that Europe was set to miss goals on reducing the use of antibiotics, ...
emjreviews.com2d
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 ...
pharmaphorum5d
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)
About AVT23 AVT23 is a monoclonal antibody and proposed biosimilar to Xolair ® (omalizumab). AVT23 is an investigational compound and has not received regulatory approval in any country. Biosimilarity ...
Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer’s Disease
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and (Nasdaq: BIIB, Corporate headquarters: Cambridge, ...
precisionmedicineonline8h
AstraZeneca's Tagrisso Gets Nod From EMA's CHMP in Unresectable EGFR-Mutated NSCLC
If approved by the EC, Tagrisso will be the first targeted therapy for European patients with unresectable EGFR-mutated cancer.
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 ...