New Drug Application

Soccer ball flying into a net scoring a goal

Biotech

Sellas’ AML asset tied to 50% response rate in certain patients

Sellas’ investigational CDK9 inhibitor has scored in a midstage AML study, demonstrating an ORR of more than double the 20% goal.

Gabrielle Masson Jul 15, 2025 10:34am

Image of a neon sign with the word no lit up next to an unlit yes

FDA shares more than 200 CRLs for now-approved drugs

Jul 10, 2025 10:54am

Cartoon of humanoid robot sitting at computer working

FDA hopes AI can deliver 'rapid or instant' reviews

Jun 11, 2025 12:45pm

red tape delay stop error tie down stall

FDA misses PDUFA date for Stealth’s ultra-rare disease candidate

Apr 30, 2025 9:00am

cancer target detection radiopharma radio

Corcept's phase 3 cancer win sends stock skyrocketing 85%

Mar 31, 2025 10:25am

black and white art of eyes

2 eye disease biotechs merge, set sights on FDA approval

Dec 12, 2024 11:05am