accelerated approval

Karyopharm
Pharma

Karyopharm reports Xpovio miss, FDA filing in separate cancers

Reporting a new miss in one cancer indication, Karyopharm is plowing ahead with plans to advance its XPO1 inhibitor Xpovio in another.
Fraiser Kansteiner Jul 31, 2026 10:00am
hearing audio waves

Regeneron ushers in new era with inaugural gene therapy approval

Apr 23, 2026 3:22pm
FDA

More transparency, evidence needed for accelerated nods: ICER

Apr 17, 2026 11:22am
opening door to brick wall
Favicon Fierce Biotech

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

Feb 26, 2026 3:50pm
U-turn pivot about-face

Atara, Pierre Fabre receive 2nd US rejection for Ebvallo

Jan 12, 2026 11:30am
sarepta building

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

Nov 4, 2025 7:56am