Targeted Oncology

NDA for Rusfertide Submitted to FDA for Polycythemia Vera

A new drug application (NDA) has been submitted to the FDA seeking approval of rusfertide, an investigational hepcidin ...
Yahoo Finance

Aquestive Therapeutics Announces Positive Topline PK Results from its Pediatric Study and Completes the NDA Submission for Anaphylm™ (epinephrine) Sublingual Film

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 ...
Pharmabiz

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 ...
Forbes

New Study Reveals The Toll NDAs Impose On Harassment And Discrimination Victims

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 ...
Nasdaq

Crinetics Pharmaceuticals Reports Progress on Paltusotine NDA and Atumelnant Phase 3 Study Amid Strong Financial Position

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 ...