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Gottlieb Worried About RFK Jr. Pick for HHS

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Former FDA Commissioner Scott Gottlieb predicts a difficult path for Robert F. Kennedy Jr. to win Senate confirmation as HHS secre...

J&J Seeks Tremfya Approval for Pediatric Uses

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Johnson & Johnson files two supplemental BLAs for Tremfya (guselkumab) for treating certain children with moderate-to-severe plaqu...

Applied Therapeutics NDA Denied Approval

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FDA issues Applied Therapeutics a complete response letter on its NDA for govorestat and its use for treating classic galactosemia...

FDA OKs Mentor's Larger Breast Implants

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FDA approves a Mentor Worldwide PMA for its MemoryGel Enhance Breast Implants for reconstruction breast surgery in post-mastectomy...

Circulating Tumor DNA Use Guidance

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FDA publishes a guidance to help sponsors planning to use circulating tumor DNA as a biomarker in some cancer trials.

Patheon Italia FDA-483 Out

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FDA releases the form FDA-483 with four observations from a 2023 inspection at the Monza, Italy-based Patheon Italia sterile drug ...

Follow-up Testing for Ames-Positive Drugs Guide

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Federal Register notice: FDA makes available a draft guidance entitled Recommended Follow-up Testing for an Ames-Positive Drug (Ac...

Guide on Assessing Ovarian Toxicity

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Federal Register notice: FDA makes available a draft guidance entitled Assessment of Ovarian Toxicity in Premenopausal Adults Duri...

Oncologic Drugs Advisory Committee Renewal

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Federal Register notice: FDA renews its Oncologic Drugs Advisory Committee for an additional two years.

8 GDUFA Science and Research Priorities

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FDA identifies eight broad areas for the GDUFA FY 2025 science and research priorities.