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Latest From Novaliq GmbH

New Drugs For Gastric Cancer, Liver Disease Among 14 Products Heading For EU Approval

Two orphan drugs are among a host of products that the European Medicines Agency’s human medicines committee has OKd for pan-EU approval.

Europe Drug Review

EU Moment Of Truth For Lecanemab & 14 Other Drugs

Eisai/Biogen could this week learn whether the European Medicines Agency will give the thumbs up to market lecanemab across the EU for early Alzheimer’s disease.

Europe Drug Review

Pharma Looks To America First: US FDA Holds Overwhelming Lead Over EMA In Novel Approvals

A Pink Sheet analysis finds US approval preceded European Union clearance for 80% of products approved in both areas, but when EU approval came first, it beat the FDA by a median of 13 months. US-first approvals came close to six months before the EU.

Regional Comparisons Approvals

OKYO Hits Multiple Dry Eye Endpoints, Plans Move Into Phase III

OKYO’s eye drop OK-101 has hit endpoints for ocular pain, tear film breakup time and conjunctival staining in Phase II, while demonstrating a placebo-like tolerability profile.

Clinical Trials Drug Approval Standards
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