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Latest From AbbVie Inc.

Sun’s Leqvelsi Must Now Shine In Crowded JAK Inhibitor Field

The US FDA approved Leqvelsi for alopecia areata, making it the third drug in the class for the indication after Lilly’s Olumiant and Pfizer’s Litfulo.

Approvals Launches

US FDA Bids Adieu To Allergenic Products Adcomm; Vaccines Panel To Take Over Duties

The effort and expense to maintain the committee, which met only 10 days in the past 15 years, can no longer be justified, the FDA said. The terminated panel’s responsibilities will be integrated into the Vaccines and Related Biological Products Advisory Committee.

Advisory Committees Biologics

PDUFA Meetings: US FDA Wants Sponsors To Prioritize Issues For Discussion

But the agency should explain why different meeting types are granted than requested or denied entirely, industry representatives said during session on meeting management best practices.

User Fees Research & Development

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
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    • Luminera
    • Mavupharma
    • Pharmacyclics, Inc.
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