FDA Approves Pembrolizumab for BCG-Unresponsive, High-Risk Bladder Cancer
January 9th 2020The FDA approved pembrolizumab (Keytruda) for the treatment of patients who are unresponsive to Bacillus Calmette-Guerin (BCG) treatment with high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
FDA Grants Breakthrough Therapy Designation for GVHD Prevention Drug
December 4th 2019The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to abatacept (Orencia) to prevent moderate or severe acute graft-versus-host disease (GvHD) in patients who underwent a hematopoietic stem cell transplant and are not related to their donors, according to Bristol-Myers Squibb, the manufacturer of the drug.