On Jan. 14, 2025, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) announced…
On Apr. 14, 2023, Revance Therapeutics announced that the U.S. Food and Drug Administration (FDA) had approved the…
On Nov. 2, 2022, AIM ImmunoTech announced that the U.S. Food and Drug Administration had granted Orphan Drug…
On Aug. 24, 2022, BioMarin Pharmaceutical announced that the European Commission (EC) had granted conditional marketing authorization (CMA)…
On Oct. 8, 2020, the FDA announced that it had awarded six new clinical trial research grants to…
On Jun. 29, 2017, the U.S. Food and Drug Administration (FDA) unveiled a strategic plan to completely eliminate…
On May 1, 2012, the U.S. Food and Drug Administration (FDA) approved new orphan drug Elelyso to treat…
In 1987, the U.S. Food and Drug Administration (FDA) announced revised regulations regarding Expanded Access (EA) to investigational…
On Jan. 3, 1983, the Orphan Drug Act was passed by the U.S. Congress with the leadership of…