Jazz Pharmaceuticals plc has reported that the Biologics License Application for zanidatamab, has been accepted and given Priority Review status by the U.S. Food and Drug Administration.
Jun 6th latest updates in the global new drug development field, including progress in new drug research and development, transaction information, and partnership developments.
Astellas Pharma Inc. revealed that the U.S. Food and Drug Administration has recognized their resubmission of the Biologics License Application for zolbetuximab.
Johnson & Johnson has applied to the European Medicines Agency for approval of a subcutaneous version of RYBREVANT® (amivantamab) to treat patients with EGFR-mutated non-small cell lung cancer.
Bristol Myers Squibb has revealed that the U.S. Food and Drug Administration has given the green light to Breyanzi® (lisocabtagene maraleucel; liso-cel).
On June 3, the official website of Structure Therapeutics announced top-line data from its 12-week clinical Phase 2a study of the investigational drug GSBR-1290 in obesity.
Jun 5th latest updates in the global new drug development field, including progress in new drug research and development, transaction information, and partnership developments.
On May 22, Biogen Inc. and Human Immunology Biosciences (HI-Bio) announced an acquisition agreement. Biogen will acquire HI-Bio for $1.15 billion upfront and up to $650 million in potential milestone payments.