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 ...
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 ...
WARREN, N.J., April 01, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful ...
A new drug application (NDA) has been submitted to the FDA seeking approval of rusfertide, an investigational hepcidin ...
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 ...
Reports positive pharmacokinetic (PK) results from the recently completed pediatric study for Anaphylm™ Completes submission of its New Drug Application (NDA) for Anaphylm to the FDA; NDA acceptance ...