Pharmaceutical

Jaguar Health Makes Submission to EMA Regarding EU Approval Pathway for Canalevia for General Diarrhea in Dogs Based on Data from Completed Study

Jaguar's requesting advice from EMA on EU approval pathway for general diarrhea of FDA conditionally approved Canalevia®A novel non-antibiotic approach...

Orbus Therapeutics Announces Publication of Phase 3 STELLAR Clinical Study Results Showing Clinically Meaningful Improvements in Rare Brain Tumor in Journal of Clinical Oncology (JCO)

– Eflornithine and lomustine combination doubled progression free survival (PFS) and improved overall survival (OS) in patients with recurrent Grade...

Dogwood Therapeutics Files New Synthetic Halneuron(R) Intellectual Property Protection Projected to Extend Exclusivity Period Up to 2045

- New Composition of Matter Intellectual Property ("IP") Filing Centered on First-in-Class, Fully Synthetically Manufactured Halneuron®-- New Synthetic Process to...

Palisade Bio Strengthens Clinical Leadership Team with Appointment of James Izanec, MD, AGAF as Vice President, Clinical Development

Veteran gastroenterologist and clinical development leader with deep expertise driving global Phase 2/3 programs across immunology, neurology, and gastrointestinal disease...

AIML Subsidiary NeuralCloud Enters Pilot with Cornerstone Physiotherapy to Deploy MaxYield(TM) and Insight360(TM) for Elite Athlete Cardiac Performance Testing

Early collaboration supports development of Cornerstone's emerging athlete-performance program and extends NeuralCloud's ECG analytics into sports-science and human performance marketsPilot...

Biofrontera Inc. Announces Filing of Supplemental New Drug Application (sNDA) for the Treatment of Superficial Basal Cell Carcinoma (sBCC) with Ameluz®-PDT

sNDA for treatment of sBCC with Ameluz®-PDT submitted to U.S. Food and Drug Administration (FDA) on November 28, 2025First Phase...

NRx Pharmaceuticals Announces US Food and Drug Administration (FDA) Receipt of ANDA for KETAFREE™, a Preservative-Free IV Ketamine

FDA has determined that NRx’s Abbreviated New Drug Application (ANDA) is “substantially complete” and received for review. Assigned GDUFA goal...

Fulcrum Therapeutics to Host Investor Event to Review New Clinical Data from the PIONEER trial of Pociredir in Sickle Cell Disease on December 7, 2025

CAMBRIDGE, Mass., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on developing...

First U.S. Commercial Sale of KOMZIFTI™ Triggers $135 Million Milestone Payment to Kura Oncology Under Collaboration and License Agreement with Kyowa Kirin

SAN DIEGO, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”), a biopharmaceutical company committed to realizing the...

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