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Doctor, Staff Charged with Falsifying Trial Data

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The Department of Justice says a federal grand jury has indicted the co-owner of Floridas Pine Care Research Center and two staff ...

17 Senate Democrats Hit HHS on FDA, Other Changes

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Some 17 Senate Democrats write to HHS secretary Robert F. Kennedy Jr., questioning many of his personnel decisions and expressing ...

Zasocitinib Beats Sotyktu in Head-to-Head Study: Takeda

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Takeda says its investigational TYK2 inhibitor zasocitinib performed significantly better than Bristol Myers Squibbs Sotyktu in a ...

CGMP Violations Seen in Port Jervis Records Review

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FDA cautions Port Jervis Laboratories in Port Jervis, NY, about CGMP violations in its manufacturing of over-the-counter drugs.

Risk Management an Ever-Evolving Responsibility: Thomas

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CDRH associate director for compliance and quality Keisha Thomas tells the RAPS Quality Conference about FDAs new Quality Manageme...

Congressional Report Outlines FDA Oversight of AI-Enabled Devices

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A new Congressional Research Service report outlines FDAs evolving approach to regulating artificial intelligence-enabled medical ...

Early Alert on Baxter Volara Breathing Device Circuits

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FDA issues an early alert regarding a potentially high-risk issue affecting certain patient circuits used with Baxter's Volara Sys...

FDA Authorizes 1st Generic Animal Drug for New World Screwworm

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FDA authorizes Felix Pharmaceuticals generic nitenpyram tablets to treat New World screwworm infestations in dogs and cats.

FDA Issues 2nd Complete Response Letter on Acromegaly Drug

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FDA sends a second complete response letter to Camurus regarding its NDA for Oclaiz (octreotide), an extended-release injection un...

Kidney Risk in OTC Weight Loss Drug Alli

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FDA approves labeling changes for Haleons OTC weight loss drug alli to warn of the rare risk of kidney injury associated with its ...