FDA Grants Breakthrough Status to Sutacimig Therapy
CAMBRIDGE, Massachusetts, USA & COPENHAGEN, Denmark — March 5, 2026 Hemab Therapeutics, a clinical-stage biotechnology company focused on developing...
FDA Breakthrough Therapy Designation
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FDA Breakthrough Status Advances Rett Syndrome Gene Therapy
DALLAS, Oct. 2, 2025 — The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to TSHA-102,...
NATCO Launches Generic Bosentan Tablets for Oral Suspension in the U.S. with 180-Day Exclusivity
Hyderabad, India, August 20, 2025 – NATCO Pharma Limited (BSE: 524816 and NSE: NATCOPHARM) today announced the launch of...
SmartLabs and Sonrai Form Exclusive AI Partnership to Accelerate Precision Medicine and Scientific Discovery
SmartLabs and Sonrai Analytics today announced a global strategic alliance to integrate Sonrai’s next-generation AI platform, Sonrai Discovery, into...
Stramsen Biotech Submits Pre-IND Package to FDA for SBX1977, Seeks Phase 2 Pathway in Wound Care
Stramsen Biotech Inc., a plant-based biotechnology company, has announced the submission of its Pre-Investigational New Drug (Pre-IND) package to...
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D3 Bio Wins FDA Breakthrough and Orphan Drug Designations for D3S-001 in KRAS G12C-Mutated Cancers
Shanghai – August 28, 2025 — D3 Bio, Inc., a clinical-stage precision oncology company, announced that the U.S. Food...
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