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Multiple Violations at Chinas Xiamen Kang

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FDA warns Chinas Xiamen Kang Zhongyuan Biotechnology Co. about producing drugs in insanitary conditions and making misleading or d...

New FDA AEMS Dashboard Needs Context, Transparency: Professors

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Two pharmacy professors say FDA needs to solicit expert and client input on its new Adverse Event Monitoring System dashboard and ...

FDA Accepts Roche sBLA for Gazyva in Lupus

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FDA accepts a Roche supplemental BLA that seeks to expand use of Gazyva to treat Systemic Lupus Erythematosus.

Makary Support Vouchers for Psychedelic Therapies

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FDA commissioner Marty Makary tells Fox Business that the agency will deploy its new national priority voucher program to signific...

FDA Approves Mercks Idvynso for Treating HIV

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FDA approves Mercks Idvynso, a once-daily, single-tablet regimen for adults with HIV-1 who are already virologically suppressed.

Outlook Therapeutics Completes FDA Dispute Meeting on Lytenava

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Outlook Therapeutics completes a formal dispute resolution meeting with FDA as part of the companys push to revive its approval pr...

UCSF Radiopharmaceutical Facility CGMP Issues

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FDA warns the University of California at San Francisco radiopharmaceutical facility about CGMP violations in its production of fi...

CGMP Violations at Par Health USA/Endo USA

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FDA warns Par USA/Endo USA about CGMP violations in its manufacturing of finished drugs.

FDA Lays Out Next Phase of Plan to Reduce Animal Testing

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FDA outlines expanded efforts to reduce animal testing in drug development after reporting significant first-year progress under i...

Trump Signs Executive Order to Accelerate Psychedelic Therapies

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President Trump signs an executive order aimed at accelerating the development and availability of psychedelic-based treatments fo...