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PDL BioPharma, Inc.

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Latest From PDL BioPharma, Inc.

EU New Drug Approvals Hit Record High

Chaos wrought by the ongoing coronavirus pandemic. A heavy workload and continuing resource constraints at the European Medicines Agency. Nonetheless, a record number of novel drugs and vaccines were cleared for marketing in the EU last year.

Europe Approvals

Yescarta, Breyanzi Offer Practice-Changing Options For Second-Line LBCL

Data at ASH show CAR-T therapies may replace standard of care in an earlier line of large B-cell lymphoma with similar response rates and event-free survival for Kite’s established Yescarta and Bristol’s newer Breyanzi.

Clinical Trials ImmunoOncology

Holding ANDA Labeling Review Until Late Cycle Could Minimize Delays From Last-Minute Changes

A GDUFA III adjustment could allow more labeling changes during the review cycle and reduce assessment cycles.

Generic Drugs User Fees

Holding ANDA Labeling Review Until Late Cycle Could Minimize Delays From Last-Minute Changes

A GDUFA III adjustment could allow more labeling changes during the review cycle and reduce assessment cycles.

Generic Drugs User Fees
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Company Information

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  • Pharmaceuticals
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      • Antibodies
  • Other Names / Subsidiaries
    • Eos Biotechnology, Inc.
    • LENSAR, Inc.
    • Noden Pharma DAC
    • Noden USA
    • Protein Design Labs, Inc.
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