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Biologics License Application

Janssen Reports BLA Submission of Amivantamab to the US FDA for Metastatic NSCLC with EGFR Exon 20 Insertion Mutations

Janssen Reports BLA Submission of Amivantamab to the US FDA for Metastatic NSCLC with EGFR Exon 20 Insertion Mutations

  • December 4, 2020
Samsung Bioepis and Biogen Report the FDA's Acceptance of BLA for SB11 Proposed Biosimilar to Lucentis

Samsung Bioepis and Biogen Report the FDA's Acceptance of BLA for SB11 Proposed Biosimilar to Lucentis

  • November 18, 2020
Celgene and Acceleron Pharma Submit Biologics License Application (BLA) to the US FDA for Luspatercept

Celgene and Acceleron Pharma Submit Biologics License Application (BLA) to the US FDA for Luspatercept

  • April 8, 2019
Regeneron and Sanofi Announces Acceptance of sBLA for PRALUENT's by the US for the Treatment of Reduction in MACE

Regeneron and Sanofi Announces Acceptance of sBLA for PRALUENT's by the US for the Treatment of Reduction in MACE

  • September 12, 2018
Merck's Keytruda sBLA Receives FDA Priority Review for Treatment of Locally Advance or mMCC

Merck's Keytruda sBLA Receives FDA Priority Review for Treatment of Locally Advance or mMCC

  • September 4, 2018
Bio-Thera Announces BLA Acceptance of Humira's Biosimilar (BAT1406) by China National Drug Administration (CNDA)

Bio-Thera Announces BLA Acceptance of Humira's Biosimilar (BAT1406) by China National Drug Administration (CNDA)

  • August 24, 2018
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