The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...

Pharmacoequity requires policies geared at equitable access to the right medicine for all individuals — regardless of race, ethnicity or socioeconomic status. This should be our north star.

The FDA approved Zegfrovy for advanced non-small cell lung cancer with EGFR exon 20 mutations after chemotherapy.

Ultragenyx Pharmaceuticals' GTX-102 earns FDA Breakthrough status after early data shows sustained progress in Angelman syndrome patients.

The FDA plans to approve selected high-priority drug application submissions in 1 to 2 months rather than 10 to 12.

Datroway received accelerated FDA approval for adults with EGFR+ advanced non-small cell lung cancer after EGFR-targeted and ...

Ultragenyx Pharmaceutical received breakthrough therapy designation from the U.S. Food and Drug Administration for its drug GTX-102, which is designed to treat people with Angelman syndrome. Angelman ...