The NDA is supported by data from a clinical trial that compared the absorption and efficacy of the nasal treatment with oral and IV bumetanide in 68 healthy adults.

XORTX’s presentation will be recorded and available after the conference on the Company’s website. About XORTX Therapeutics Inc.

Then, on December 2, 2024, Applied Therapeutics disclosed it received a "warning letter" from the FDA referring to the clinical trial issues underlying the CRL. Applied Therapeutics' common stock fell ...

The US Court of Appeals for the Federal Circuit reversed a district court’s ruling of invalidity for lack of written description, finding that ...

Vanda Pharmaceuticals Inc. (Vanda) today provides an update on the tradipitant development program. Gastroparesis is a ...

Highlights faulty FDA review WASHINGTON, Jan. 27, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today provides an update on the tradipitant ...

FDA Prescription Drug User Fee Act (PDUFA) target date is March 27, 2025. Milestone's New Drug Application (NDA) for CARDAMYST™ (etripamil) nasal spray, its lead investigational product, for the ...

After Discontinuation of Treatment with QRX003 Complete Reversal of Positive Clinical Improvements Across all Measured Endpoints ...

THE LAWSUIT: A class action securities lawsuit was filed against Applied Therapeutics, Inc. that seeks to recover losses of shareholders who were adversely affected by alleged securities fraud between ...

Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced its 2025 priorities and upcoming ...