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ZyVersa Touts Approval Path for Kidney Disorder Drug

[ Price : $8.95]

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

FDA Like Flat Earthers Taking Over NASA: Woodcock

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

FDA OKs Opdivo/Yervoy in Colon Cancer

[ Price : $8.95]

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

Multiple Violations at EpiCare Acquisitions

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

Bausch Recalls Intraocular Lenses After Reports

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

Laboratory-Developed Test Decision Reviewed

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

User Fee Programs are in Jeopardy: FDA Watchers

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

Restrict 2 Opioid Indications: Petition

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Physician Douglas Smith petitions FDA to take 11 steps to curtail the use of the indications of opioid addiction and opioid use di...

Rhythm Pharma Positive Data on Obesity Drug

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Rhythm Pharmaceuticals announces positive topline results from the pivotal Phase 3 TRANSCEND trial evaluating setmelanotide for tr...

Teva Files sBLA to Expand Migraine Therapys Use

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FDA accepts for review a Teva Pharmaceuticals supplemental BLA for Ajovy (fremanezumab-vfrm) to expand the indication to include p...