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, calling for action to prevent antimicrobial resistance from undermining ...
precisionmedicineonline1h
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.
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 ...
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 ...