Day: December 2, 2025

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...

SeaStar Medical Announces FDA Approval of Reduction in Mandatory Enrollment for SAVE Surveillance Registry Evaluating QUELIMMUNE™ Safety for Pediatric AKI

FDA lowers surveillance requirement to 50 patients from 300 patients in original HDE approval based on assessment of first 21...

BioNexus Gene Lab Corp. (Nasdaq: BGLC) Secures $500 Million Equity Facility From ARC Group International to Support Expansion of Precision Diagnostics, CDMO Operations, and Therapeutic Commercialization

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...

Oncotelic and Sapu Nano Unveils Broad-Applicability Deciparticle™ Nanomedicine Platform Capable of Formulating Multiple Hydrophobic Peptide, Macrolide, and Polyketide Drugs

AGOURA HILLS, Calif., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. (OTCQB: OTLC) 45% owned Joint Venture, Sapu Nano, a...

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