This blog delves into the rise of rare disease drug approvals and the critical importance of regulatory guidance in shaping ...

Areas of regulatory focus included the accelerated approval programme ... with the oncology community to foster efficient drug development.

Since the Orphan Drug Act went into effect in 1983, more than 600 drugs have been approved for rare diseases, according to ...

China continues to boost pharmaceutical innovation through regulatory reforms and as a result, "the pace of new drug approvals has significantly accelerated, positioning the country as an ...

The U.S. Food and Drug Administration is replacing animal testing with human-relevant methods, including artificial ...