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 ...

TOKUSHIMA, Japan--(BUSINESS WIRE)--150 patients have been enrolled at the multi-clinical centers in US to the Phase 3 randomized trial of DFP-10917 vs non-intensive reinduction (LoDAC, Azacytidine, ...

Forbes contributors publish independent expert analyses and insights. Kim Elsesser covers issues that impact women in the workplace. Organizations regularly use non-disclosure agreements (NDAs) to ...

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 ...

CEO Rick Stewart stated that "Achieve is on track to submit the NDA for cytisinicline next month." He emphasized that "all internal resources are now focused on a successful NDA submission, acceptance ...

The FDA issued a complete response letter to Aldeyra Therapeutics Inc's (NASDAQ:ALDX) New Drug Application (NDA) of reproxalap, an investigational drug candidate for dry eye disease. Although no ...

Takeda (TSE:4502/NYSE:TAK) and Protagonist Therapeutics (Nasdaq: PTGX) (“Protagonist”) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking ...

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 ...