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BioWorld - Friday, May 9, 2025

505(b)(2)

Home » Topics » Regulatory » 505(b)(2)
  • Dec. 24, 2024
    By Randy Osborne

    Any Betta? FDA adds Ensacove to ALK lung cancer weaponry

    A Chinese player entered the U.S. non-small-cell lung cancer (NSCLC) arena as the U.S. FDA cleared Xcovery Holdings Inc.’s Ensacove (ensartinib) as a first-line therapy for adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic disease who have not previously received an ALK-inhibitor. Xcovery, of Palm Beach Gardens, Fla., is a subsidiary of Betta Pharmaceuticals Co. Ltd, of Hangzhou, China.
  • Dec. 19, 2024
    By Randy Osborne

    Any Betta? FDA adds Ensacove to ALK lung cancer weaponry

    A Chinese player entered the U.S. non-small-cell lung cancer (NSCLC) arena as the U.S. FDA cleared Xcovery Holdings Inc.’s Ensacove (ensartinib) as a first-line therapy for adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic disease who have not previously received an ALK-inhibitor. Xcovery, of Palm Beach Gardens, Fla., is a subsidiary of Betta Pharmaceuticals Co. Ltd, of Hangzhou, China.

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