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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...

Cell/Gene Therapy Guide on Common Questions

[ Price : $8.95]

FDA posts a draft guidance entitled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products.

Aldeyra Dry Eye NDA Accepted for Review

[ Price : $8.95]

FDA accepts for review an Aldeyra Therapeutics NDA for reproxalap, an investigational topical new drug candidate for treating sign...

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...

Takeda Slapped with 4-Item FDA-483

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FDA issues Takeda Pharmaceutical a four-item Form FDA-483 after inspecting the firms Yamaguchi, Japan manufacturing facility and f...

Martinez Permanently Debarred Over Trial Data

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Federal Register notice: FDA permanently debars Ivette Maria Portela Martinez from providing services to a person that has an appr...

Hydrocortone Not Withdrawn Over Safety/Efficacy

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Federal Register notice: FDA determines that Mercks Hydrocortone (hydrocortisone sodium phosphate) injection was not withdrawn due...

GAO Report Urges Key Strategies for FDA Rare Disease Efforts

[ Price : $8.95]

A new Government Accountability Office report urges three key strategies for FDAs programs for advancing rare disease products.