Sanofi Rilzabrutinib Wins Japan Orphan Status
Paris, March 2, 2026 Sanofi announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted orphan drug...
regulatory approval
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EU Clears ANKTIVA–BCG for Bladder Cancer Therapy
Conditional Approval Expands Access to 33 Countries February 18, 2026 | Culver City, California ImmunityBio announced that the European...
Corify Unveils First Whole-Heart Mapping in a Single Beat
Madrid | January 28, 2026 — Corify Care, a cardiovascular MedTech innovator, announced a major advancement in cardiac electrophysiology...
IRLAB Wins Approval for Phase Ib IRL757 Parkinson’s Trial
Gothenburg, Sweden | December 23, 2025 — IRLAB Therapeutics AB announced that it has received regulatory and ethical approvals...
NMPA Approves MYQORZO in China for Obstructive HCM
SOUTH SAN FRANCISCO, Calif., Dec. 17, 2025 — Cytokinetics, Incorporated (NASDAQ: CYTK) announced that MYQORZO® (aficamten) has received approval...
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PharmaDrug Restructures Debt to Strengthen Biopharma Pipeline
Toronto, Ontario – October 31, 2025 — PharmaDrug Inc. (CSE: PHRX; OTC Pink: LMLLF), a specialty pharmaceutical company focused...
Nxera Expands Asian Manufacturing for QUVIVIQ to Boost Supply and Profitability
TOKYO, Japan – October 31, 2025 — Nxera Pharma Co., Ltd. announced that its subsidiary, Nxera Pharma Japan, has...
Tosoh Bioscience Gains FDA 510(k) Clearance for Rapid GR01 HbA1c Analyzer
Grove City, Ohio – October 30, 2025 — Tosoh Bioscience, Inc., a global leader in clinical diagnostics and laboratory...
FDA Accelerates First-Ever Barth Syndrome Therapy, FORZINITY™
NEEDHAM, Mass., September 19, 2025 – Stealth BioTherapeutics Inc. today announced that the U.S. Food and Drug Administration (FDA)...
IceCure Receives U.S. Patent Allowance for XSense Cryoprobe Technology
September 18, 2025 — Caesarea, Israel IceCure has been granted a Notice of Allowance by the U.S. Patent and...
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