Writing in a in a New England Journal of Medicine article, FDA officials encourage novel approaches for developing psychedelic drugs for mental health...
Rep. Diana Harshberger introduces legislation to aid the dietary supplement industry by changing FDAs drug preclusion rules.
Ovid Therapeutics executive chairman Jeremy Levin says FDA needs to speed its regulatory processes if it wants to persuade companies to conduct Phase ...
FDA grants Bayer an accelerated approval for Hyrnuo (sevabertinib), a kinase inhibitor for certain adult patients with locally advanced or metastatic ...
Rezolute says FDA is still reviewing the additional data the agency requested from the companys Phase 3 sunRIZE trial of ersodetug to treat hypoglycem...
FDA accepts for review a Nanoscope Therapeutics BLA seeking approval for Mogenry, an optogenetic gene therapy designed for vision restoration in patie...
FDA grants breakthrough therapy designation for UCBs Cimzia in some pregnant women with antiphospholipid syndrome.
The CDER Accelerated Rare disease Cures Program issues a strategic plan for 2025-2030 with goals and strategic objectives for each goal.
