One of the FDA’s recently departed top officials is weighing in on the wide-ranging staff cuts at the agency and how they ...

The Food and Drug Administration (FDA) has granted clearance for the investigational new drug (IND ... Skaggs Institute for Innovative Medicines biologics vice-president Travis Young said ...

and has been at the FDA since 2012, leading the CBER – which has responsibility for regulating vaccines – since 2016. The Biotechnology Industry Organization (BIO) issued a statement shortly ...

Dr. Peter Marks, who has led the FDA’s Center for Biologics Evaluation and Research (CBER), stepped down on Friday after earlier in the day he was given a choice to either resign or be ...

BrainStorm (BCLI) submitted an Investigational New Drug, or IND ... plan is in line with the FDA’s expectations, validating its potential to support a future Biologics License Application.