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FDA General

User Fee Programs are in Jeopardy: FDA Watchers

FDA regulatory experts warn that the agencys user fee programs could be in jeopardy based on sweeping layoffs and political indifference which threate...

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Human Drugs

Restrict 2 Opioid Indications: Petition

Physician Douglas Smith petitions FDA to take 11 steps to curtail the use of the indications of opioid addiction and opioid use disorder in drug manuf...

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Human Drugs

ZyVersa Touts Approval Path for Kidney Disorder Drug

ZyVersa Therapeutics says a new regulatory development could significantly shorten the path to approval for treatments targeting focal segmental glome...

FDA General

FDA Like Flat Earthers Taking Over NASA: Woodcock

Three former FDAers warn of a slow-moving catastrophe coming for the agency as it loses staff and resources under leaders who have unconventional view...

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Human Drugs

FDA OKs Opdivo/Yervoy in Colon Cancer

FDA approves Bristol Myers Squibbs combination of Opdivo (nivolumab) with Yervoy (ipilimumab) for treating certain adult and pediatric patients 12 yea...

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Medical Devices

Multiple Violations at EpiCare Acquisitions

FDA warns Lawrenceville, NJ-based EpiCare Acquisitions about Quality System and other violations in its manufacturing of a family of laser systems.

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Medical Devices

Bausch Recalls Intraocular Lenses After Reports

Bausch + Lomb recalls its enVista intraocular lenses after the company received reports of complications, which it says could not immediately be expla...

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Medical Devices

Laboratory-Developed Test Decision Reviewed

Six Sidley attorneys raise several practical questions arising from a Texas federal court decision finding that FDA does not have legal authority to r...

Biologics

Allogene Gets 3 Fast Tracks for Cell Therapy

FDA grants Allogene Therapeutics three fast track designations for ALLO-329, an investigational dual-targeted CD19/CD70 allogeneic CAR T cell therapy ...

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Human Drugs

Kennedy Senate Hearing Postponed

A Senate HELP Committee postpones a hearing tentatively planned for 4/10 because HHS secretary Robert F. Kennedy, Jr. reportedly could not appear this...