Singh maintained guidance that "we'll see top line results released before the end of this calendar quarter, so by the end of this calendar year" for PALISADE-3. Singh projected that top line results ...

Cytokinetics, Incorporated (CYTK) is gearing up to complete its rolling NDA submission of aficamten for the treatment of patients with obstructive hypertrophic cardiomyopathy [oHCM] in Q3 of 2024.

On-track progress for the New Drug Application (NDA) for paltusotine, with a PDUFA target action date set for September 25, 2025, indicating strong engagement with the FDA. Marketing authorization ...

Takeda & Protagonist submit NDA to US FDA seeking approval for rusfertide to treat polycythemia vera: Osaka, Japan Wednesday, January 7, 2026, 17:00 Hrs [IST] Takeda, focused on c ...