News

Aquestive Therapeutics Receives U.S. FDA Orphan Drug Exclusivity for Libervant® (diazepam) Buccal Film in Pediatric Patients with Seizure Clusters Ages Two to Five

U.S. FDA Orphan Drug exclusivity provides seven years of market exclusivity for Libervant® (diazepam) Buccal Film in the United States...

Ultragenyx Submits Biologics License Application to the U.S. FDA for UX111 AAV Gene Therapy for the Treatment of Sanfilippo Syndrome Type A (MPS IIIA)

If approved, UX111 would be the first approved therapy in the U.S. for Sanfilippo Syndrome Type ANOVATO, Calif., Dec. 19,...

Xilio Therapeutics to Present Initial Phase 2 Data for Vilastobart (XTX101), a Tumor-Activated Anti-CTLA-4, in Combination with Atezolizumab in Patients with Metastatic Microsatellite Stable Colorectal Cancer at ASCO GI 

Clearside Biomedical Announces Publication of Critical Insights into Retinal Drug Development in the Peer-Reviewed Scientific Journal, Eye

ALPHARETTA, Ga., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies...

Lifecore Biomedical Selected by Nirsum Labs to Provide CDMO Services Supporting Clinical Development of Innovative Opioid Use Disorder Treatment

Development Services Span Tech Transfer, Process Assessment and Method Validation for Fill and Finish of NRS-033 for Planned Phase 2...

NMD Pharma Announces Publication of Phase 1 Clinical Trial Data Evaluating NMD670 in Healthy Volunteers in the Journal Clinical Pharmacology & Therapeutics 

Aarhus, Denmark, 19 December 2024 – NMD Pharma A/S, a clinical-stage biotech company dedicated to developing novel and improved treatments...

Nurix Therapeutics Receives U.S. FDA Fast Track Designation for NX-5948 for the Treatment of Relapsed or Refractory Waldenstrom’s Macroglobulinemia

Fast track designation follows positive Phase 1 data presented at the 12th International Workshop on Waldenstrom’s MacroglobulinemiaSAN FRANCISCO, Dec. 19,...

Bio-Path Holdings Announces Preclinical Testing of BP1001-A as Potential Treatment for Obesity in Type 2 Diabetes Patients Enhances Insulin Sensitivity

Preclinical Studies Confirmed BP1001-A Mechanism of Action and Therapeutic Potential in Obesity and Type 2 DiabetesHOUSTON, Dec. 19, 2024 (GLOBE...

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