NDA Preparation Strategy 2026: NDA 1 2026 exam is scheduled for April 12, 2026. With only a few months left, candidates should start preparing for the exam. Begin by reviewing the latest syllabus and ...
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 ...
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 ...
Takeda & Protagonist submit NDA to US FDA seeking approval for rusfertide to treat polycythemia vera
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 ...
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Takeda and Protagonist seek FDA approval for rusfertide to treat PV
Takeda and Protagonist Therapeutics have jointly submitted a NDA seeking approval from the US FDA for rusfertide to treat ...
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, ...
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