Denali Therapeutics has become the latest on a growing list of biotechs to experience an FDA review delay in recent months. The agency in July accepted an application for Denali's enzyme replacement ...

Denali Therapeutics Inc. DNLI announced that the FDA has extended its review timeline of the Biologics License Application (“BLA”) for pipeline candidate, tividenofusp alfa. The BLA is seeking ...

A Denali Therapeutics drug for the rare enzyme deficiency Hunter syndrome is still in pivotal testing, but the company has guidance from the FDA on a pathway to get this therapy to the market sooner.

KNOXVILLE, Tenn. (WVLT/Gray News) - A family in Tennessee is dealing with a rare disease for a second time. Only about one out of every 100,000 children are diagnosed with Hunter Syndrome, but the ...

Some parents-to-be have to face the terrifying news that their unborn child has been diagnosed with a life-threatening genetic disorder. But thanks to a medical team at a Bay Area hospital, there is ...