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FDA Publishes Drug Filing Checklists, Issues First-Ever Emergency Use for Animal Drug

WASHINGTON, D.C. — The U.S. Food and Drug Administration announced two major actions last week: making its internal drug application checklists public to improve transparency and issuing the ...
FierceBiotech

FDA delays decision on Biohaven's rare disease drug filing, plans adcomm

Biohaven is giving investors whiplash. Forty-eight hours after saying its filing was on track, the biopharma revealed the FDA has delayed an approval decision on its rare disease candidate troriluzole ...
Nasdaq

FDA Extends Review Period of Sanofi's Multiple Sclerosis Drug Filing

Sanofi SNY announced that the FDA has extended the target action date for its new drug application (NDA) for tolebrutinib by three months. The NDA is seeking approval of tolebrutinib, an oral and ...
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Why is Aldeyra Therapeutics stock surging after FDA delayed its dry eye drug decision?

・The FDA delayed its decision on the dry eye drug Reproxalap without raising new issues. ・The FDA pushed the PDUFA deadline to March 16, 2026, after requesting a clinical study report already reviewed ...
Seeking Alpha

Spectral Medical Inc. (EDT:CA) Discusses Year-End Update: FDA Filing Timeline, Tigris Trial Results, and Commercialization Readiness Transcript

Ali Mahdavi - Spinnaker Capital Markets Inc. Scott McAuley - Paradigm Capital Inc., Research Division Greetings. Welcome to Spectral Medical Year-end 2025 Corporate Update End Year Review Call.
Morningstar

C2N Submits U.S. FDA Regulatory Filing for Its Alzheimer’s Disease Blood Test

Company Seeks to Establish a First in the Field of Medicine with Pioneering Diagnostic Algorithm Test Using High Resolution Mass Spectrometry C2N Diagnostics, a world leader in advanced brain health ...