Category: ADC Therapeutics

  • Insights+: The US FDA New Drug Approvals in April 2021

    The US FDA has approved 3 NDAs and 2 BLAs in April 2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 24 novel products in 2021. Additionally, last year in 2020, the US […]

  • FDA sets May date for verdict on ADC’s lymphoma drug Lonca

    ADC Therapeutics could claim its first product approval in the US next May, after the FDA started a priority review of lead drug Lonca for diffuse large B-cell lymphoma (DLBCL), an aggressive form of non-Hodgkin’s lymphoma. Lonca – short for loncastuximab tesirine (formerly ADCT-402) – is an antibody-drug conjugate that combines an antibody against CD19 […]