accelerated approval

MPS Families Carry Coffin to FDA

Biotech

Rare disease advocates stage 'funeral' at FDA, make 4 demands

More than 100 marchers carried a coffin to the FDA in a symbolic protest highlighting lives they say could be lost to regulatory delays.

Gabrielle Masson Mar 18, 2026 5:25pm

Three stacked cups with coffee spilling out of top one

Inovio trims team as trouble brews at FDA for rare disease drug

Mar 13, 2026 10:03am

opening door to brick wall

Senate hearing takes aim at FDA's rare disease review process

Feb 26, 2026 3:50pm

FDA

FDA outlines draft policy on MRD for accelerated approval

Jan 21, 2026 2:55pm

sarepta building

Fierce Pharma

Sarepta, despite key trial flop, will seek full nod for DMD meds

Nov 4, 2025 7:56am

Stock decreasing graphic

Applied Tx's stock drops on non-update for rare disease asset

Sep 29, 2025 10:57am