FDA biosimilar approvals set for record-breaking year amid US pricing reforms
The FDA approved 19 biosimilars in 2024, a sharp jump from the five greenlit by the agency in 2023.
16 May 2025
16 May 2025
The FDA approved 19 biosimilars in 2024, a sharp jump from the five greenlit by the agency in 2023.
The FDA has approved MSD’s Welireg for rare adrenal tumours, and AbbVie’s Emrelis for treating c-Met+ lung cancer patients.
AI is now used throughout clinical trials, from recruitment to analysis – but are regulators keeping up?
The new drug application was supported by positive interim data from the APeX-P trial.
The Milan Cell and Gene Center of Excellence at AGC Biologics will produce LVV material for Treg cell therapy candidates.
Proceeds from the round will be channelled into progressing the company's clinical-stage pipeline.
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