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Tag: safety profile

Creative Medical Technology Holdings Secures FDA Fast Track Designation for CELZ-201-DDT – Advancing Breakthrough Therapy for Chronic Lower Back Pain

PHOENIX, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a clinical-stage biotechnology company focused on regenerative and immune cellular therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead investigational therapy, CELZ-201-DDT, for the treatment of degenerative disc disease (DDD), a major cause of chronic lower back pain and disability.

Telitacicept Meets Primary Endpoint in Phase III Trial for Primary Sjögren’s Syndrome in China

YANTAI, China, Aug. 13, 2025 /PRNewswire/ -- On August 13th, Remegen (688331.SH/09995.HK) announced that its global first-in-class BLyS (BAFF)/APRIL dual-target fusion protein drug, Telitacicept, met...

New Study Confirms LP815® Probiotic Reduces Canine Anxiety and Aggression

With behavioral issues affecting up to 85% of dogs, LP815 provides a clinically supported approach to ease anxiety, reduce aggression, and support more restful,...

FDA Approves BRINSUPRI™ (brensocatib) as the First and Only Treatment for Non-Cystic Fibrosis Bronchiectasis, a Serious, Chronic Lung Disease

— Approximately 500,000 U.S. Patients Are Diagnosed with Non-Cystic Fibrosis Bronchiectasis (NCFB), a Progressive Disease That Can Lead to Permanent Lung Damage — — BRINSUPRI 10...

Novartis announces both ianalumab Phase III clinical trials met primary endpoint in patients with Sjögren’s disease

Ad hoc announcement pursuant to Art. 53 LR NEPTUNUS-1 and NEPTUNUS-2 are the first ever global Phase III trials to demonstrate statistically significant reduction in...

2025 Report: “PurDentix Reviews and Complaints” Surge Reflects Growing Curiosity Around Oral Microbiome Supplements

Consumer Search Data Reveals Expanding Curiosity Around Oral Probiotics and Ingredient Transparency in 2025
Consumer Search Data Reveals Expanding Curiosity Around Oral Probiotics and Ingredient Transparency in 2025

Edesa Biotech Reports Fiscal 3rd Quarter 2025 Results

TORONTO, Aug. 08, 2025 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today reported financial results for the three and nine months ended June 30, 2025 and provided an update on its business.

Femasys Announces Second Quarter Financial Results for 2025

-- Continued Progress on Regulatory Approvals and Global Commercialization of Fertility Portfolio --

ATLANTA, Aug. 08, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced its financial results for the second quarter of 2025.

Palisade Bio Reports 100% Clinical Response in Phase 1b Ulcerative Colitis Cohort with Novel PDE4 Inhibitor, PALI-2108

PALI-2108 demonstrated to be safe and well tolerated with no serious adverse events (SAEs)

Lilly reports second-quarter 2025 financial results and raises guidance

Revenue in Q2 2025 increased 38% to $15.56 billion driven by volume growth from Zepbound and Mounjaro. Increased the midpoint of our 2025 full-year...

Implantica announces second publication of groundbreaking 5-year results from the landmark RefluxStop® clinical study

VADUZ, Liechtenstein, Aug. 7, 2025 /PRNewswire/ -- Implantica AG (publ), a leading medtech company pioneering advanced implantable medical technologies, today announced the second peer-reviewed...

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