The decision is based on one of the most comprehensive real-world adolescent neuromodulation datasets ever submitted to the agency: tracking 1,120 adolescents treated across 35…
November 13, 2025
November 03, 2025
FibroBiologics Q3 Update: Advancing Toward First-in-Human DFU Study
FibroBiologics, Inc. (Nasdaq: FBLG), a clinical-stage biotechnology company with over 270 issued and pending patents, is focused on developing fibroblast-based therapeutics to address chronic diseases….
October 30, 2025
Flatiron Unveils 6 AI-Driven Hematology Datasets to Revolutionize Blood Cancer Research
Flatiron Health, a trailblazer in healthtech and real-world oncology research, has announced the launch of six groundbreaking hematology Panoramic datasets. This milestone represents a pivotal…
October 29, 2025
Medicus Pharma Collaborates with Gorlin Syndrome Alliance to Advance Compassionate Use of SKINJECT™ for Rare Skin Cancer Patients
Medicus Pharma (NASDAQ: MDCX), a biotech and life sciences company dedicated to advancing innovative therapeutic assets, has announced a strategic partnership with the Gorlin Syndrome…
October 27, 2025
UroGen Pharma Secures Permanent J Code for ZUSDURI™
UroGen Pharma (NASDAQ: URGN) has announced that the Centers for Medicare and Medicaid Services (CMS) has assigned a permanent J Code (J9282) for ZUSDURI, its…
Rani Therapeutics (NASDAQ: RANI) revealed a licensing agreement with Chugai Pharmaceutical (a 60% subsidiary of Roche [RHBBY]) for its RaniPill technology. The deal was accompanied…
October 17, 2025
Artiva’s AlloNK Secures FDA Fast Track Designation for Refractory Rheumatoid Arthritis; Stock Climbs
Artiva Biotherapeutics, Inc. (NASDAQ: ARTV), a clinical-stage biotech company, announced on Friday that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation…
October 09, 2025
Telomir Pharmaceuticals Unveils Breakthrough Discovery: Telomir-1 Targets Aggressive Triple-Negative Breast Cancer Cells
Telomir Pharmaceuticals, Inc. (NASDAQ: TELO), a preclinical-stage biotechnology company focused on developing therapies for cancer, aging, and age-related diseases, has announced groundbreaking findings regarding its…
September 29, 2025
Dogwood Therapeutics Secures Exclusive License for SP16 to Address Cancer-Related Pain in Groundbreaking All-Stock Deal
Dogwood Therapeutics, Inc. (Nasdaq: DWTX), a clinical-stage biotechnology company dedicated to developing innovative treatments for pain and neuropathy, has announced a transformative licensing agreement with…
September 25, 2025
PepGen Inc. Announces $100 Million Public Offering to Advance Clinical Development
PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company focused on developing next-generation oligonucleotide therapies, has announced the pricing of an underwritten public offering of 31,250,000…
September 05, 2025
BioNTech and Duality Biologics Announce Breakthrough Success with BNT323 in Phase 3 Clinical Trials for Breast Cancer
BioNTech (NASDAQ: BNTX) and its partner, Duality Biologics, have announced a major milestone in their oncology program. Their experimental drug, BNT323, has successfully achieved its…
July 07, 2025
Denali Therapeutics’ Experimental Therapy for Hunter Syndrome Gains Priority FDA Review
Denali Therapeutics (Nasdaq: DNLI) announced that the FDA has accepted its Biologics License Application (BLA) for tividenofusp alfa and granted the therapy Priority Review for…