accelerated approval

Doctor holding diagram of kidneys
Pharma

Hansa eyes FDA filing after ph. 3 win for kidney transplant med

With a late-stage win in hand, Sweden’s Hansa Biopharma is one step closer to bringing its kidney transplant drug imlifidase to the U.S.
Fraiser Kansteiner Sep 25, 2025 12:37pm
road through forest

Stealth scores FDA approval for 1st Barth syndrome treatment

Sep 19, 2025 6:00pm
Genentech

FDA rejects Roche's earlier DLBCL bid over lackluster US data

Jul 18, 2025 1:32pm
Pfizer

ASCO: Pfizer's Braftovi combo slashes death risk in rare cancer

May 30, 2025 8:00am
rare diseases
Favicon Fierce Biotech

Stealth CEO questions FDA rejection of rare disease drug

May 29, 2025 2:27pm
AbbVie

AbbVie's ADC bet pays off with FDA nod for Emrelis

May 14, 2025 3:39pm