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Cell/Gene Therapy Product Frequent Questions

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Frequently Asked Questions Developing Potential Cellular a...

Jesduvroq Not Withdrawn Over Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that GlaxoSmithKlines Jesduvroq (daprodustat) tablets were not withdrawn due to safety or ...

Advisors Asked About Generative AI Regulation

[ Price : $8.95]

FDA asks members of its Digital Health Advisory Committee to spend two days discussing agency questions about its role in regulati...

Astellas Gets Complete Response on Izervay sNDA

[ Price : $8.95]

FDA sends Astellas Pharma a complete response letter on a supplemental NDA for Izervay (avacincaptad pegol intravitreal solution) ...

Stakeholder Comments on Oncology Trial Guidance

[ Price : $8.95]

Three stakeholders raise concerns about an FDA draft guidance on considerations for generating clinical evidence from multiregiona...

Subcutaneous Keytruda is Noninferior to IV Formulation: Merck

[ Price : $8.95]

Merck reports positive topline results from a trial that evaluated the noninferiority of subcutaneous administration of Keytruda (...

Panel Input Sought on Andexxas Thrombosis Risk

[ Price : $8.95]

FDA seeks input 11/21 from its Cellular, Tissue, and Gene Therapies Advisory Committee about AstraZenecas Andexxa and an increased...

GSK Liver Disease Anti-Itch Drug Meets Endpoint

[ Price : $8.95]

GSK says its Phase 3 GLISTEN trial evaluating linerixibat in adults with a relentless itch associated with primary biliary cholang...

FDA Warns Unexo Lifesciences Over CGMP

[ Price : $8.95]

FDA warns New Delhi, India-based Unexo Lifesciences about CGMP and other violations in its production of finished drugs.

BrightHeart AI Review of Heart Ultrasounds Cleared

[ Price : $8.95]

FDA clears a BrightHeart 510(k) for its artificial intelligence software for reviewing prenatal ultrasound evaluations of the feta...