ARWR READ THE FULL ARWR RESEARCH REPORT Business Update Plozasiran Update On January 17, 2025, Arrowhead Pharmaceuticals, Inc. (NASDAQ:ARWR) announced that the U.S. Food and Drug Administration (FDA) ...
The table below is a review of notable updates that occurred in January 2025 for investigational products in development.
Q1 2025 Earnings Call Transcript February 10, 2025 Arrowhead Pharmaceuticals, Inc. misses on earnings expectations. Reported EPS is $-1.39 EPS, expectations were $-0.42. Chris Anzalone: Thanks, Vince.
NDA review period extended Plozasiran (Arrowhead ... or metastatic pheochromocytoma and paraganglioma. sNDA accepted for Priority Review Datopotamab deruxtecan (AstraZeneca and Daiichi Sankyo ...
ITCI has also filed a supplemental new drug application (sNDA) to the FDA seeking approval ... J&J began the submission of a new drug application (NDA) with the FDA for TAR-200, its innovative ...
The FDA’s decision on the sNDA is expected on May 26, 2025. The NDA was based on data from the phase II LITESPARK-015 study. Welireg is currently approved in the United States for patients with ...
Sanofi SNY and Roche RHHBY announced their fourth-quarter and full-year 2024 results. Novo Nordisk’s NVO novel obesity ...
The outcomes are to be included in an NDA submission, and Cellectar will be ... A Supplemental New Drug Application (sNDA) submission to the FDA for VTAMA cream, 1% is expected to be made by ...
The NDA submission is supported by previously disclosed results ... formulation to support a planned 2026 sNDA filing. If approved, the ODT formulation would provide people living with HAE with an ...
Company completed Type C meeting with FDA, aligning on its plan to submit an sNDA; submission expected around end of 1Q25 If approved, FILSPARI could be the first and only approved medicine ...