The last couple of weeks has been particularly distressing for Duchenne muscular dystrophy patients and their families. The ...

But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...

Shipment of delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy (DMD), will resume following a ...

Dr Vinay Prasad has resigned from the FDA after less than three months amid controversy over Sarepta Therapeutics' gene ...

Shares of Sarepta Therapeutics ($SRPT) jumped over 14% on Tuesday after the FDA authorized the company to restart shipments ...

Moderna CEO Stéphane Bancel said in an email to employees that the company made "every effort" to avoid layoffs that will ...

Vinay Prasad, head of the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), has stepped down, with market analysts forecasting a boost to the cell and ...

Alnylam Pharma raised its revenue outlook as its heart drug sees quick uptake.

George Tidmarsh has only been at the Center for Drug Evaluation and Research for nine days, but will now add supervision of a ...

The Food and Drug Administration’s polarizing vaccine chief is leaving the agency after a brief tenure that drew the ire of ...