The approval was based on data from the phase 3 ASPEN trial. The Food and Drug Administration (FDA) has approved Brukinsa ® (zanubrutinib) for the treatment of adults with Waldenström ...
BASEL, Switzerland & CAMBRIDGE, Mass.--(BUSINESS WIRE)--BeiGene (NASDAQ: BGNE; HKEX: 06160) announced today that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has ...
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Credit: Shutterstock. The Food and Drug Administration has ...