FDA Seeks Input on Generative AI Medical Device Rules
Silver Spring, Maryland, August 18, 2026 The U.S. Food and Drug Administration (FDA) has issued a new discussion paper...
Regulatory Science
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FDA Expands Regulatory Flexibility for Cell and Gene Therapies
White Oak, Maryland – January 2026 — The U.S. Food and Drug Administration has announced a more flexible regulatory...
uBriGene Launches GMP LVV Turbo Platform with UltraCell Integration
CAMBRIDGE, Massachusetts, December 17, 2025 — uBriGene, a leader in advanced biopharmaceutical manufacturing, has launched LVV Turbo™, its next-generation...
Envoy Medical Secures Patent Advancing Cochlear Implant Signal Quality
SYDNEY, Australia, December 17, 2025 — Envoy Medical, Inc. has been granted a new Australian patent for its innovative...
CTT Pharma Publishes Peer-Reviewed Drug Delivery Research
BOSTON, Massachusetts — December 16, 2025 — CTT Pharmaceutical Holdings, Inc. (CTT Pharma) announced that its scientific team has...
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In-Silico Trials Surge as AI Transforms Drug & Device R&D
AUSTIN, Texas & TOKYO — November 27, 2025. A new global analysis reports that the In-Silico Clinical Trials (IST)...
FDA Approves TEZSPIRE for Chronic Rhinosinusitis with Nasal Polyps
THOUSAND OAKS, Calif., October 17, 2025 — In a landmark regulatory decision, the U.S. Food and Drug Administration (FDA)...
Novavax’s Nuvaxovid™ 2025–2026 Formula COVID-19 Vaccine Approved in the U.S.
GAITHERSBURG, Md., August 27, 2025 – The U.S. Food and Drug Administration (FDA) has granted approval for Novavax’s Nuvaxovid™...
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