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February PDUFA Catalysts Biotech Investors Must Know: Sanofi’s Bleeding Disorder Drug, Regeneron’s Twin Eylea Label Expansions, 3 Delayed Approvals And More

The year has started well for biopharma companies on the regulatory front, as most decisions handed out during January were positive. The Food and Drug Administration has already cleared four new molecular entities for the year.

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Regeneron, Sanofi Announced Earlier , Dupixent Recommended For Expanded EU Approval By The CHMP To Treat Children As Young As Six Months Old With Severe Atopic Dermatitis

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Dupixent® (dupilumab), recommending expanded approval in the European Union (EU) to treat severe atopic dermatitis in children 6 months to 5 years old who are candidates for systemic therapy.

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