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Tuesday, June 2, 2026

Tag: toxicity

Nxera’s Vamorolone Granted Key Regulatory Designations Supporting Faster Access for Duchenne Muscular Dystrophy Patients in South Korea

Tokyo, Japan and Cambridge, UK, 2 June 2026 – Nxera Pharma Co., Ltd. (“Nxera” or the “Company”)  announces that the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea has granted Orphan Drug Designation (ODD) and Global Innovative Products on Fast Track (GIFT) designation to vamorolone for the treatment of Duchenne muscular dystrophy (DMD). The Company plans to submit a Marketing Authorization Application (MAA) for vamorolone in South Korea during 2026.

Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia

Tonmya is the first FDA-approved therapy for the treatment of fibromyalgia in over 15 years

AIM ImmunoTech Reports Second Quarter 2025 Financial Results and Provides Corporate Update

Continued progress across pipeline programs with focus on pancreatic cancer

24/7 Market News: LIXTE Biotech Advances Precision Oncology Pipeline with First Phase 1B/2 Trial Readout Expected in 2H 2025

2H 2025 is shaping up to be a defining year for LIXTE (Nasdaq: LIXT) and its lead compound LB-100

VivoSim Labs Appoints Tony Lialin as Chief Commercial Officer

Veteran commercial leader to scale AI-enabled NAMkind™ liver and intestine toxicology services in a rapidly growing market
Veteran commercial leader to scale AI-enabled NAMkind™ liver and intestine toxicology services in a rapidly growing market

Santhera Secures Agreement with GEN for the Distribution of AGAMREE® (Vamorolone) in Türkiye

Pratteln, Switzerland, 13 August, 2025 – Santhera Pharmaceuticals (SIX: SANN) announces the signing of an exclusive agreement with Gen İlaç ve Sağlık Ürünleri San. ve Tic. A.Ş. (GEN) for the distribution and promotion of AGAMREE® (vamorolone) in Türkiye for the treatment of Duchenne muscular dystrophy (DMD) in patients four years of age and older.

Tumor-Infiltrating Lymphocyte Therapy Market Gains Momentum with Expanding Oncology Applications | DelveInsight

Over the last ten years, cell-based immunotherapy has emerged as a promising approach for treating solid tumors. Several companies, including Iovance Biotherapeutics, Obsidian Therapeutics,...

Tumor-Infiltrating Lymphocyte Therapy Market Gains Momentum with Expanding Oncology Applications | DelveInsight

Over the last ten years, cell-based immunotherapy has emerged as a promising approach for treating solid tumors. Several companies, including Iovance Biotherapeutics, Obsidian Therapeutics,...

Azitra, Inc. Announces Q2 2025 Results and Provides Business Updates

BRANFORD, Conn., Aug. 11, 2025 /PRNewswire/ -- Azitra, Inc. ("Azitra") (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for...

Azitra, Inc. Announces Reverse Stock Split

Common Stock Will Begin Trading on a Split-Adjusted Basis on August 21, 2025 BRANFORD, Conn., Aug. 11, 2025 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a...

Booking Health Unveils New Study: Role of Immunotherapy in Extending Life Expectancy for Stage4 Cervical Cancer Patients

Langenfeld, Germany, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Booking Health, a global leader in medical treatment coordination, today unveiled a new study titled Role of Immunotherapy in Extending Life Expectancy for Stage 4 Cervical Cancer Patients. The report outlines how cutting-edge immunotherapy is reshaping care for women with advanced cervical cancer, offering new pathways to longer survival and improved quality of life, particularly in cases resistant to standard treatments.

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...

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