The upcoming IND application outlines XORTX’s clinical development plan and its goal to file an NDA following the completion of the two-part XRX-OXY-102 clinical trial. This trial is designed to ...

The US Food and Drug Administration (FDA) recently released a transparency roadmap outlining its achievements in FY 2026 and ...

CALGARY, Alberta, Sept. 18, 2026 (GLOBE NEWSWIRE)-- XORTX Therapeutics Inc. ("XORTX" or the "Company") (NASDAQ: XRTX), a late-stage clinical pharmaceutical company focused on developing innovative ...

Arkayli BioPharma Inc. ("Arkayli"), a biopharmaceutical company dedicated to developing innovative therapies for rare dermatologic conditions, today announced that the U.S. Food and Drug ...

Drug developer Saniona has completed the toxicology studies and CMC activities required ahead of an IND application for drug candidate SAN2465. The company said so in a press release.Saniona is ...

Vancouver, British Columbia--(Newsfile Corp. - June 22, 2026) - BetterLife Pharma Inc. (CSE: BETR) (OTCQB: BETRF) (FSE: NPAU) ("BetterLife" or the "Company") today ...

Atrium Therapeutics gets a Hold as key risks include unproven human efficacy and clinical and regulatory uncertainties. Click ...

FDA grants Type B pre-IND meeting, enabling critical alignment with the Agency on the development strategy for RTX-NP Oddifact and Mabion aim to bring rituximab's well-established activity in ITP to ...

Silver Spring, MD, Sept. 15, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today announced the final design of the Expedited Investigational New Drug (IND) Pilot. Accelerating ...

The U.S. Food and Drug Administration has unveiled the final design of its Expedited Investigational New Drug (IND) Pilot, a new program intended to shorten the time it takes for drug developers to ...

Investigational New Drug application planned for submission to the U.S. FDA in the fourth quarter of 2026, advancing the Company’s regulatory path toward NDA filing for gout program XRx-026 CALGARY, ...