Zebra Biologics Inc.
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Latest From Zebra Biologics Inc.
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.
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.
New Oncologics Overwhelmingly Approved In US Before EU
Ninety-five percent of novel cancer treatments approved in both the US and Europe received the FDA’s OK first, but Europe usually followed within a year, a Pink Sheet analysis shows.
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.
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- Industry
- Biotechnology
- Pharmaceuticals
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Biotechnology
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Large Molecule
- Antibodies
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Large Molecule
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