The CDER Accelerated Rare disease Cures Program issues a strategic plan for 2025-2030 with goals and strategic objectives for each goal.
AstraZeneca reports data from the Phase 3 OBERON and TITANIA trials showing that tozorakimab is the first biologic to demonstrate statistically signif...
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.
FDA warns Stephen Fallon of Wilton Manors, FL, about bioresearch violations in his role as clinical investigator of a trial of an investigational prod...
FDA cautions Fenwal International about CGMP deviations at its Maricao, Puerto Rico, facility that manufactures blood pack units.
